The Process Engineer will provide technical expertise in Upstream/Downstream processing to support the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility. The role will ensure leadership for on-going optimization of the Upstream/Downstream process and act as a manufacturing Subject Matter Expert (SME) in supporting and ensuring the continued manufacture and supply of quality biologic products.
- Apply scientific/engineering principles to support process deviations and provide product impact assessments.
- Provide expertise in the design, commissioning and qualification of the new manufacturing facility; through to commercialisation, ensuring all necessary plans are executed and delivered on
- Provide technical knowledge in establishing the commercial process and routine manufacturing operations by serving as a commercial manufacturing process
- Be the escalated point of contact when trouble shooting process issues during start-up, tech transfer activities and commercial
- Work closely with the extended manufacturing team ensuring any actions and plans are clearly understood and accounted for in alignment with plant operations
- The Process Engineer will Identify and lead process improvement projects and cost reduction projects and work cross functionally to prioritise projects/support demands from the Business
- Implement process CAPA’s and performance improvements, conduct investigation
- Author or review, and approve process validation strategies, protocols and
- Coaching fellow process engineer/scientist and manufacturing personnel to increase technical knowledge of critical process steps and develop plans to build competencies and
- You should have a degree in Science or Engineering with substantial experience in Upstream and/or Downstream processing in a large-scale biopharmaceutical facility with demonstrated expertise.
- Experience working within a start-up biologics facility would be very beneficial.
- Experience in the design and execution of process validation studies
If you’d like to work within a state of the art start up biopharmaceutical facility on one of Irelands most exciting expansion projects get in touch now!
Excellent career progression opportunities and remuneration packages on offer.
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