JOHNSON & JOHNSON

Responsibility

• at the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease
• transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us
• attends/participates in investigator meetings as needed
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• we bring together the best minds and pursue the most promising science
• we collaborate with the world for the health of everyone in it
• develop, deploy and maintain tactical account business plans that align to business and customer objectives to deliver agreed goals
• ensures appropriate follow-up of pre-trial visit activities
• learn more at www.janssen.com and follow us @JanssenGlobal
• prepare appropriate plans to meet with customers in order to deliver on account plans and landmarks
• ensures site study supplies are adequate for trial conduct
• co-create site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas
• the Global Clinical Operations team at Janssen Pharmaceuticals is recruiting for an Early Development & Clinical Pharmacology Trial Manager located in the United Kingdom
• participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
• janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies
• ensure key insights from the external marketplace are appropriately shared internally to shape future business plans
• contributes to the development of study management documents at a country level or initiates development of these documents for trials
• ensure competence in procedural focus area and product portfolio
• acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution
• ensure strict adherence to investigational product preparation and administration guidelines
• be the local expert in assigned protocols and build the necessary therapeutic area knowledge
• coach or mentor less experienced colleagues
• responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies
• ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation
• present brand value propositions and valuable customer solutions to positively influence buying behaviors
• besides the LTM tasks, a STM may also carry out Global Trial Leader tasks for ED&CP studies which follow the ED&CP hybrid oversight model. The STM may also perform Site Manager tasks
• responsible for activities ranging from site feasibility and selection over site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and site/study close-out in complex clinical trials
• the TM performs the Local Trial Manager tasks and may perform the Site Manager tasks
• maintains and updates trial management systems. Uses study tools and management reports/dashboards available to analyse trial progress
• analyse and interpret account strategies and plans utilizing key systems and data, both internally and externally. Where appropriate, gain a broad understanding of the business environment and insights into account needs
• ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level
• collaborates with the Function Manager for performing study feasibility and site assessments, providing recommendation of suitable sites for selection to participate in the trials
• contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
• responsible for the implementation of a site-level analytical risk-based monitoring model and for working with the site to ensure timely resolution of issues and deviations identified during monitoring visits
• A TM may contribute to process improvement initiatives and training of Clinical Trial Assistants and Site Managers
• ensure accuracy and completeness of all trial data including safety data. Manage timely data entry and query resolution in collaboration with site staff
• contribute and collaborate with colleagues in regional teams to work collaboratively towards regional business planning goals
• tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments
• ensures appropriate documentation and follow-up related to protocol issue escalation
• A TM will usually perform principal responsibilities under the direct supervision of an a Functional Manager
• works with the GPL , GTL, country TMs , FM and other study team members to select final site list
• understand technical information pertinent to the procedure and product platform
• in collaboration with Site Investigational Product Specialist and Pharmacy Investigational Product Specialist , ensures that clinical drug supplies are appropriately handled, administered and stored
• may assist Contract & Grant for negotiation of trial site contracts and budget
• principal Responsibilities
• may participate to process improvement and training

Requirements

• education and Experience
• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field is required
• power Tools equipment sales experience with a proven track record of success is required
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• bachelor’s degree or equivalent is required
• minimum one to two years of pharmaceutical and/or clinical trial experience required
• an experienced sales professional with experience in Animal Health and exposure of having worked within the veterinary environment
• A passion and awareness of marketing product management
• master’s degree in business administration will be preferred
• experience in mentoring/coaching. Strong leaderships skills, ability to lead initiatives
• understanding of the drug development process including ICH/GCP and local regulatory requirements
• able to demonstrate strong selling & negotiating skills and be able to effectively plan
• driver’s License is required
• further qualifications in L&D area will be a plus Certification, AGILE methodology, etc)
• excellent communication skills, written, spoken and presentation ability
• excellent written and oral communication skills
• haematology experience required
• orthopaedics is preferrable
• A minimum of 10 years of business experience
• phase 1 trial experience essential
• able to demonstrate excellent commercial acumen
• excellent written, presenting, and oral communication skills are required
• willingness to travel with occasional overnight stay away from home. Role requires 1-2 days onsite at High Wycombe office per month
• skilled at influencing and business partnering
• passion for Talent Development
• some leadership skills
• experience translating business strategies into learning solutions
• ability to build trust with customers that help the customer achieve their objectives, acting in a consultative manner
• good communication and computer skills required
• minimum four years of clinical trial management experience is preferred. Other relevant experiences and skills may also be considered
• and with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind
• project and vendor management
• who are we looking for?

Benefits

• mutual

Earnings for position development manager

Responsibility

• at the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease
• transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us
• attends/participates in investigator meetings as needed
  Show more +45
• we bring together the best minds and pursue the most promising science
• we collaborate with the world for the health of everyone in it
• develop, deploy and maintain tactical account business plans that align to business and customer objectives to deliver agreed goals
• learn more at www.janssen.com and follow us @JanssenGlobal
• prepare appropriate plans to meet with customers in order to deliver on account plans and landmarks
• ensures site study supplies are adequate for trial conduct
• co-create site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas
• the Global Clinical Operations team at Janssen Pharmaceuticals is recruiting for an Early Development & Clinical Pharmacology Trial Manager located in the United Kingdom
• participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
• janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies
• ensure key insights from the external marketplace are appropriately shared internally to shape future business plans
• ensure competence in procedural focus area and product portfolio
• acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution
• ensure strict adherence to investigational product preparation and administration guidelines
• be the local expert in assigned protocols and build the necessary therapeutic area knowledge
• coach or mentor less experienced colleagues
• responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies
• ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation
• present brand value propositions and valuable customer solutions to positively influence buying behaviors
• responsible for activities ranging from site feasibility and selection over site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and site/study close-out in complex clinical trials
• the TM performs the Local Trial Manager tasks and may perform the Site Manager tasks
• analyse and interpret account strategies and plans utilizing key systems and data, both internally and externally. Where appropriate, gain a broad understanding of the business environment and insights into account needs
• ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level
• contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
• responsible for the implementation of a site-level analytical risk-based monitoring model and for working with the site to ensure timely resolution of issues and deviations identified during monitoring visits
• A TM may contribute to process improvement initiatives and training of Clinical Trial Assistants and Site Managers
• ensure accuracy and completeness of all trial data including safety data. Manage timely data entry and query resolution in collaboration with site staff
• contribute and collaborate with colleagues in regional teams to work collaboratively towards regional business planning goals
• tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments
• A TM will usually perform principal responsibilities under the direct supervision of an a Functional Manager
• understand technical information pertinent to the procedure and product platform
• in collaboration with Site Investigational Product Specialist and Pharmacy Investigational Product Specialist , ensures that clinical drug supplies are appropriately handled, administered and stored
• principal Responsibilities
• may participate to process improvement and training
• the TM is responsible for local management of a trial in a country and acts as a key point of contact at a country level for assigned studies, assisting in operational oversight of assigned protocol from start-up to database lock and closeout activities
• the TM is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures , Good Clinical Practice , and regulatory requirements
• 8.Oversees the maintenance to trial trackers and systems to analyze feasibility, start up activities and project support as delegated by the lead TM/FM
• build strong networks of relationships that enable the identification of mutually beneficial opportunities to sell key technologies in the surgical procedural environment
• ensures full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trials manager and central study teams
• may participate to process improvement and training. Leads and/or participates in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'
• 9.Monitors country progress on key study metrics and communicates study progress and issues to study management teams
• respond to requests for support from other customer facing colleagues and proactively share information and insights where the customer may be shared across the customer relationship management system
• develop positive relationships and partnerships with Key Opinion Leaders to support ACUVUE® and contact lens category advocacy
• implements any local criteria for site selection according to the ED&CP decision tree
• 12.Complies with relevant training requirements and assists teams in management of training requirements into J&J systems

Requirements

• education and Experience
• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field is required
• higher qualifications in contact lens practice
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• minimum one to two years of pharmaceutical and/or clinical trial experience required
• an experienced sales professional with experience in Animal Health and exposure of having worked within the veterinary environment
• understanding of the drug development process including ICH/GCP and local regulatory requirements
• able to demonstrate strong selling & negotiating skills and be able to effectively plan
• excellent communication skills, written, spoken and presentation ability
• haematology experience required
• phase 1 trial experience essential
• able to demonstrate excellent commercial acumen
• willingness to travel with occasional overnight stay away from home. Role requires 1-2 days onsite at High Wycombe office per month
• skilled at influencing and business partnering
• some leadership skills
• ability to build trust with customers that help the customer achieve their objectives, acting in a consultative manner
• good communication and computer skills required
• proactive approach in business situations; looks to expand network continually; comfortable in meeting new people and stimulating conversation
• experience developing and delivering education
• able to understand stakeholders’ requirements, ability to analyze those requirements and develop strategies that drive the adoption of technologies and become a trusted business advisor providing solutions

Benefits

• mutual

Trade

• management
• Management

Earnings for position development manager

Responsibility

• be seen as a credible NHS engagement manager and has the ability to support and influence key NHS stakeholders
• you will be named as RP/ RPi on Janssen's WDA , MIA and Specials Licence
• determine the optimal strategy for engagement with key commercial NHS bodies in order to deliver on specific business objectives
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• this role has responsibility for delivering on commercial compliance to the UK, Ireland, and Nordic markets
• the coaching & management of CBMs to ensure appropriate identification of opportunities for business growth through commercial incentives and value creation
• this includes maximising tender opportunities and ideas for developing revenue for specific brands
• ensuring a consistent high-performance team through coaching, development and attracting top talent through “always on” recruitment
• all functions and staff are included , including 3 rd parties
• leading the sign up to the Category Towers procurement frameworks and negotiating commercial contractual sign up with the customer
• understanding how to leverage the commercial proposal to pass to drive the value-based agenda tailored to the individual trust
• aseptic units, homecare, and wholesale sectors in line with company objectives
• acts as the Controlled Substance Responsible Person for the UK LOC
• assist with Compliance programme delivery via Senior Franchise management and EMA Commercial Compliance Team
• understand and feedback on the changing NHS landscape for tenders/commercial deals and feed into the BP/LRFP process shaping best forecasting decisions
• NHS Engagement
• acts as Quality Controller and Contact Person for the PQS under the UK MIA licence
• selling the J&J Medical device commercial proposition through the relevant frameworks to develop long term partnership agreements
• some travel within EMA will be required – Up to 15%
• the CBML is the DRI for quarterly pricing reviews with the account
• the CM is the DRI for quarterly pricing reviews with the account
• develop key relationships with key NHS partners across procurement/commercial and NHS payor bodies
• accountable for local release if mandatory by local regulations
• main Responsibilities
• building strong relationships with non-clinical purchasing stakeholders to secure long-term sales growth for J&J MedTech
• selling the J&J MedTech commercial proposition through the relevant frameworks to develop long term partnership agreements
• shaping the in depth understanding of commercial selling process within the integrated account teams and the specific account
• have a repository of important collaborators across the NHS, supply chain and NHSE/CMU or payor bodies
• you will drive the co-creation of medium and long-term UK strategy by coordinating regional multi-functional teams and aligning with local teams. Represent the UK interests in regional initiatives, sharing local inputs and advocating for its needs
• leading the sign up to the Category Towers procurement frameworks and negotiating commercial contractual sign up with the customer in the NHs and Private sector
• understand and monitor supply chain processes for Janssen and competitor products Tender and rebate responsibilities
• driving market compliance reviews
• translating data insights into actions that challenge status quo and reinforce our competitive advantage across the towers
• have a repository of relationships across key procurement pharmacists and tender leads, retail and aseptics
• the position entails the identification and realization of improvement projects to maintain a favorable quality and compliance profile, as well as driving the Commercial Quality operating model via cross-functional collaboration demonstrating integration of E2E quality processes
• all areas of commercial compliance, in conjunction with relevant legal and compliance partners, including but not limited to Competition Law, Data Protection, HCBI/FCPA, Records Management, Credo, Code of Business Conduct
• being considered the business expert in Category Tower Frameworks & Private Sector, having an in-depth understanding of the framework mechanisms, Negotiations and Tender shaping and matching these to the needs of the customer
• leading the team in pricing set up and be the expert in the category tower frameworks demonstrating exceptional knowledge of how to apply our commercial proposals to the frameworks and individual accounts
• leading pricing set up and be the expert in the category tower frameworks demonstrating exceptional knowledge of how to apply our commercial proposals to the frameworks and individual accounts
• scope and present the best return of investment opportunities across commercial agreements for national and regional accounts in hospitals , retail, & 3rd parties e.g
• the incumbent will sponsor, lead or be a team member of projects at UK level as appropriate applying robust project management methodologies
• set-up effective collaborations with other functional areas such as SC QA, CLS QA, BRQC, ESIQ and PV to ensure reliable product supply that meets regulations
• driving data driven analysis of market and customer KPI’s to match the tailored commercial offer to the customer
• build and present a case for current and prospective accounts in order to keep business growth opportunities in the pipeline
• provide important business and UK input to the design of Quality Management Systems and Warehouse Quality Management Systems to ensure processes are efficient and effective
• development of closer partnerships with One MD shared service legal and HCC colleagues
• being considered the business expert in Category Tower Frameworks, having an in-depth understanding of the framework mechanisms, and matching these to the needs of the customer
• managing price, volume and mix and other commercial terms for Medical Device accounts in line with national strategy
• identifies and shapes the opportunity for the handover of a strategically important accounts to the SAM
• execute on the contract management process to minimize any delays in contract and pricing set up, and drive growth through product sale
• collaborate closely with the LSO , Regulatory Affairs Head and Medical Information Head to ensure that the LOC is managed in compliance with local regulations and company policies/procedures and in accordance with any Pharmacovigilance agreements with business partners

Requirements

• A background of working in pharmaceutical/biotechnology industries with a substantial experience of either Quality Assurance or Process methodologies. At least 10 years’ experience required
• skills and competencies required
• essential Technical Knowledge, skills and experience
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• ABPI Code of Practice
• excellent interpersonal, teamwork, and communication skills, and the demonstrated ability to work or lead in a matrix environment
• operational leadership experience
• A good understanding of the NHS as well as payor environment
• ability to analyze, balance and prioritize risk is required
• strategic & situational leadership experience
• existing relationships with key NHS payor bodies as well as key NHS partners for procurement and commissioning purposes
• strong planning and tracking skills, well -organized, results oriented, capable of managing multiple projects
• understanding of supply chain and impact on supply of drugs to the UK
• strong financial/ budgeting foundations, compliance demeanor, eye for business and intellectual curiosity
• ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description
• strong commercial acumen evidenced by experience of working with or for the NHS
• ability to influence without authority
• johnson & Johnson is an Affirmative Action and Equal Opportunity Employer
• understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes
• can delegate QH tasks to other quality workers, but the QH remains accountable for these delegated tasks
• generic drug knowledge and modelling experience
• up to date knowledge of relevant pharmaceutical legislation and GMP/GDP
• can be a SME for a certain quality topic and should represent CQ EMEA in WW discussions and developments
• handle quality issues constructively with executives as well as being capable to analyse details and to summarise status and mitigation plans
• evidenced ability to deliver multi-layer “deal making” in healthcare
• high standard of numeracy
• strong analytical, communication and decision-making skills for interaction with external and internal customers and partners
• strong customer facing skill
• procurement process knowledge
• ensure safety reporting requirements as set out in company policies and SOPs are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors
• flexible work hours and reachable in case of emergencies. Readiness to travel; amount of travel is mainly based on a case-by-case basis
• incisive thinker, confident with concepts, analysis and commercial frameworks
• A reasonable level of clinical knowledge of Janssen and competitor products
• who are we looking for?
• ensure HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors
• goals and objectives and performance management of the QH is a shared responsibility of the local dotted reporting line and regional CQ
• full UK Driving licence – 50% + travel required

Trade

• legal
• Legal

Responsibility

• collaborate with the CRM for country protocol feasibility and site feasibility assessment
• implement any local criteria for site selection
• ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report
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• you will have operational oversight of assigned protocols from start-up through to database lock
• recommend suitable sites for selection participating in trials
• set predictable and realistic start up time lines
• at Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and sophisticated diseases of our time
• excellent internal cross functional matrix leadership & collaboration skills
• johnson & Johnson Innovative Medicine, Research & Development, discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases
• we are seeking a Local Trial Manager to report to the Clinical Research Manager , running assigned clinical trials in the UK
• lead and coordinate trial activities in compliance with SOPs, other procedural documents and regulations
• lead local project planning activities to meet recruitment targets and to deliver high quality data on time and within budget
• responsibility for coordinating and leading the local trial team to deliver quality data and trial documents that are aligned with Standard Operating Procedures , Good Clinical Practice , and regulatory standards
• as a subject matter expert at system level in critical footprints to ensure optimal access & uptake of Janssen’s Oncology and Haematology medicines
• lead the Strategic Account Planning process with the local cross functional team and other leaders across the business with a focus on face-to-face business meetings, to support and develop strategies that flex around the changing local NHS needs
• the LTM will actively contribute to process improvement; training and mentoring of Clinical Trial Assistants and Site Managers roles. The LTM may have some site management responsibilities
• acting as the Assigned Protocols subject matter expert. Develop strong therapeutic knowledge to support roles and responsibilities
• works closely with the local account teams to identify areas of potential synergy and to co-develop potential opportunities for new projects with the Service & Solutions Centre of Excellence
• acting as primary country contact for a trial
• have the adaptability, insight, and judgement to prioritise opportunities and critical needs across the portfolio and with different ICSs and HBs, managing those priorities and expectations with the NMAM, Services & Solutions Centre of Excellence, local account teams and national brands teams as applicable
• post launch– ongoing optimisation of the target sites service were relevant & preparation of handover to commercial teams were required
• supervising country progress and initiate Corrective and Preventive Action when the trial deviates from plans. Identify and resolve issues
• supports sites in capacity expansion or new indications and workflow changes
• the PPM works in close alignment with internal stakeholders to coordinate and implements programs that support Abiomed mission of increasing education, awareness, and adoption of hemodynamic support
• coordinate logistics organization for all events such as travel, hotel, catering, etc
• assists sites in throughput planning
• knowledge of key regional stakeholders their networks and their decision-processes/structures
• conducts accompanied site visits with SM as delegated
• contribute and encourage process improvement at every opportunity

Requirements

• educated to degree level
• ABPI Exam Qualified
• higher level qualification desired
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• degree educated or equivalent experience
• bio/pharma experience needed, haematology / oncology or cell therapy experience desired
• subject matter expert in partnership working with NHS with excellent process capability
• strong experience in professional medical training and education and/or marketing role
• healthcare industry experience required in Cardiology, Surgery, or ICU
• excellent presentation and communication skills
• strong account management skills and strategic account plan facilitation
• site readiness experience
• critical and strategic thinking and adaptability in fast paced environment
• strong negotiation skills
• value excellence competencies
• ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description
• good Ability to handle multiple tasks with multiple stakeholders
• ability to co-create value by understanding Janssens strategic capabilities and being able to apply them to customer needs
• strategic thinking, ability to implement business plans, strong communication and negotiation skills
• readiness to travel
• establishes relationships with key stakeholders/ decision makers along the patient and product pathway for certification purposes only/launch readiness
• implementation of agreed training strategy that is tailored to the site
• ability to navigate through complex internal and external approval processes resulting in strong outcomes for patient, NHS and Janssen
• ability to cultivate senior level relationships and create partnerships with stakeholders
• strong commercial acumen and Return on Investment focus in planning
• understanding of dynamics in complex organizations and ability to influence people
• targeting and prioritisation of UK launch sites in partnership with CVT
• drives contracting process by working with legal professionals to ensure it is streamlined for hospital team
• ability to build and deliver outstanding strategic plans, which have patient access at the heart of each strategic plan
• strong TA, disease and product knowledge
• insights gathering to shape and develop UK Site Qualification/Certification and
• excellent internal and external communicator, highly engaging with external customers and curious about customer needs
• ensure safety reporting requirements as set out in company policies and SOPs are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors
• prior project management experience
• ensures implementation of defined treatment into relevant sub-national guidelines in partnership with SAM Team
• ensure HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors
• strong track record of successful engagement with clinical & non-clinical stakeholders across the UK NHS
• orchestrates delivery of site certification training, coordinating appropriate Janssen stakeholders including supply chain and medical
• deep understanding of hospital operations
• previous demonstrable experience of working in partnership with the NHS to deliver collaboration/Joint Working Initiatives
• partner with UK Opco, EMEA and Global teams were relevant to scope and define
• oversees final site activation
• strong project management skills
• if commissioning contractors or third-party organisations, put contracts in place and provide training so that these individuals also act in accordance with Johnson & Johnson HCC requirements when interacting with Healthcare Professionals and report adverse events and complaints
• ability to work effectively in cross-functional matrix to successfully deliver objectives to time and budget
• internal business processes/ system requirements to support the go to market model
• develop strategic key business questions identifying opportunities to shape & influence the UK go to market model and tactical site readiness plan, working in partnership with CVTL/SPM
• coordinates Janssen stakeholders around sites, including the UK, EMEA and Global Site readiness/Certification Team, the EMEA COE where relevant and the OpCo/cluster medical, quality, legal and supply chain teams
• mapping local patient pathways & design/implement referral strategy
• familiarity with NHS data sources

Trade

• physicians & Surgeons
• management
• Management

Responsibility

• lead small scale manufacturing and packaging engineering projects
• support and execute manufacturing validation effort for existing and new processes to deliver product excellence for the surgical user
• supports manufacturing investigations, solve technical issues and provides general technical service support for manufacturing facilities and marketed products
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• work with teams to design and build transformational manufacturing lines utilizing new intelligent technologies
• reviews and updates documentation of the production processes, recommending modifications as appropriate
• to develop an understanding of packaging waste regulations
• maintain Bills of Materials / Routings
• participate in and lead various initiatives and multi-functional investigations as and when required
• support base business value stream packaging escalations
• position: Manufacturing Engineer / Process Engineer
• job Title: Senior Manufacturing Engineer
• provides technical solution for cost improvement, business continuity and/or process excellence
• conduct investigations and execute project actions as part of the CAPA process
• reporting to: Process Engineering Lead
• performs activities including reformulation, manufacturing process improvements and validation qualification as required
• department: Manufacturing Engineering -External Tech Ops
• conduct project validation and lab-based testing as required
• location: Leeds, UK
• reports To: Manufactring Engineering Manager
• takes an active role in project team/technical project activities that focus on cost improvement, business continuity and/or process excellence
• contract: Full time/permanent
• location: UK or Ireland
• write protocols and reports for studies and process validations
• in this pivotal role, you will play a key part in supporting our external suppliers to manufacture high-quality implants and instruments, while constantly striving for process optimization and excellence
• working model : #LI-Hybrid
• this dynamic and rewarding role offers you a chance to contribute meaningfully to all of the patiens we serve while continuously expanding your skill set
• co-ordinate own week to week workload in line with your project plans and departmental priorities and overall business framework
• prepares documentation for submissions and preapproval inspections as required
• actively participates in Continuous Improvement processes within the Operations department and works multi-functional with operations, marketing, quality assurance and research and development to find opportunities for cost and process improvements
• adhere to the Change Control and Design Control requirements
• support attainment of key business metrics through the provision of maintenance support for value stream processes
• quality and Compliance Related Responsibilities
• work closely with the inhouse maintenance & calibration teams to provide engineering support where required
• ensure all process development, validation, etc. is managed in accordance with the Quality management system
• elimination of safety and quality risks in the process through the delivery of robust engineering solutions
• ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations
• technical Support: As the technical lead in our External Supplier POD structure, you will collaborate closely with Supply Chain partners and Supplier Quality to ensure seamless operations, high supplier reliability, and swift resolution of technical issues affecting product quality and delivery
• ensure timely closure of quality actions such as Audit Actions, NCR’s, CAPA’s
• support packaging audits at suppliers /J&J sites with the supplier quality initiatives
• responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance
• identifies, tests and implementation of new technologies, to ensure materials and process techniques are continuously updated, fostering production efficiency and costs improvements
• actively involved in cost saving initiatives through the delivery of scrap, reprocessing and consumable projects
• are you a passionate and innovative engineer seeking to make a significant impact in the medical industry? We are thrilled to invite you to join our team as a Manufacturing Engineer at DePuy Synthes within our External Operations team, a leading medical device company dedicated to improving patients' lives
• driving Supplier Reliability: Your expertise will be crucial in identifying, remediating, and resolving process and technical issues to enhance supplier reliability, ensuring the consistent production of our products
• design & develop tools, fixtures, gauges and special equipment for manufacturing operations
• ensure timely execution and closure of quality actions such as Audit Actions, NR’s, CAPA’s
• in this role we are looking for an engineer to lead and support the delivery of priority manufacturing and packaging-based projects from initiation through to delivery, in line with the company project portfolio and strategy

Requirements

• degree qualified in a relevant Engineering / Science subject area
• at least 4 years of manufacturing, quality engineering, or manufacturing or process engineering experience
• experience in regulated industry, FDA, ISO, etc
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• previous Supply Chain/manufacturing experience would be preferred
• degree qualified – ideally mechanical engineering
• experience with process validations/verifications
• A minimum of degree level in Engineering or relevant subject
• A minimum of 2 years of operational experience in a complex multi-national company/environment is desirable
• experience working with External Supply chain
• minimum 2 years experience of working in a manufacturing engineering, manufacturing technical support
• ability to read and understand technical documents
• great teammate with the ability to work independently
• some previous experience in medical device or related regulated industry desirable but not essential
• strong project management problem solving skills
• strong organizational abilities and a hands-on mentality
• previous experience of project management and leading of small projects desirable
• focus on patients and customers at all times
• ability to travel up to 10% domestic and international
• closing date
• experience of Audit Actions, NR’s & CAPA’s within a quality management system would be advantageous
• 28 October 2022
• experience of CAD/CAM
• minimum 2 years experience of working in a manufacturing engineering, manufacturing technical support, or a laboratory in either a company or academic environment
• some experience in FEA, DFMA, FMEA, 6 sigma and Lean
• experience of project management and problem solving
• and with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind
• knowledge of quality systems, regulatory requirements and related standards, with shown understanding of the practical application of these requirements
• when you work with us you can touch over a Billion lives worldwide every day