ScientificJobs.ie Salary
Belfast
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ScientificJobs.ie is looking for employees for positions:
manufacturing engineer
Working hours
- permanent
Responsibility
- provide expertise for all aspects of mammalian cell culture process; vial thaw through to harvest
- provide SME support for cell harvest technologies e.g., centrifugation, depth filtration and perfusion technologies
- assess and monitor culture performance through Viable cell density, metabolite and nutrient monitoring relating to cell culture performance and product quality
- SME for bioreactor control strategies, e.g.; DO, pH, feed, base CO2 etc
- provide expertise in column packing techniques and technical troubleshooting
- apply scientific principles to support process deviations and provide product impact assessments
- author APQR and process impact assessments to support investigation closure as applicable
- lead the analytical monitoring on processes such as protein concentration, impurity monitoring and clearance and the impact to product quality
Requirements
- third level qualification in a Science or Engineering related subject is essential
- substantial experience in Upstream and/or Downstream processing in a large-scale biopharmaceutical facility with demonstrated expertise
- GMP/Commercial manufacturing experience in a mammalian Cell culture and/or associated Downstream processing
- interpretation of process trends e.g. bioreactor profiles, chromatograms etc
- experience in the design and execution of process validation studies e.g. PPQ- mixing, hold, membrane and resin lifetime studies etc
- previous experience in the generation of sampling plans
- experience in a client facing role would be advantageous
- knowledge of Bioreactor design and concepts