Senior Process Engineer - Tech Transfer

DPS is a leading Project Management and Engineering Company serving industry around the world for over 40 years. Our reputation is based on forming successful partnerships with our clients, providing them with innovative designs and cost effective solutions in the context of sound  judgment, strong management and technical excellence. We employ over 1000+ people out of our twelve office locations and serve a broad range of clients ranging from multinational companies to small generic producers.  We provide Full Service Engineering for our clients  including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning,  Qualification, Professional Outsourcing and Start-up on global projects  across a range of market sectors.

Senior Process Engineer - Tech Transfer

The successful candidate will be responsible for providing scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process/continual improvement programs 

Duties & Responsibilities:

• Provide process information and analysis to facilitate process/facility fit, and qualification of a large scale Biologics facility through to NPI tech transfer startup, PPQ validation, in a multi-product facility.
• Participate in Tech Transfer Receiving Unit activities, and provide technical guidance to team members in large scale cell culture/downstream purification processes, and provide SME support for the area on key audit topics.
• Provide scientific and technical input to facilitate decision making related to Tech Transfer.
• Develop/provide deep technical knowledge and understanding in cell culture processes; vial thaw, seed expansion, seed reactors and large scale production bioreactors, including centrifugation and depth filtration steps, or downstream purification processes; large scale column chromatography steps, ultrafiltration/diafiltration steps, pH adjustment, depth/nanofiltration steps, and final fill. 
• Identify technical issues, and guide resolution of same.
• Provide SME knowledge and understanding in Biologics manufacturing processes (upstream/downstream); cause and effect, scale up principles, QRM, and process validation strategies.
• Shape and develop strategy approaches for Technical Services in areas such as cell culture and downstream purification processes, technical studies supporting facility fit and regulatory filings, Technology Transfer, PPQ, CPV approach and so forth ensuring alignment to industry regulations, trends and advances.

Requirements:

• Undergraduate degree in Chemistry, Biology, Engineering or related discipline.
• Minimum of 4 years+ experience in a pharmaceutical manufacturing organiz478293.080902ation, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations or downstream unit operations, process/facility fit, New Product Introduction Technology Transfer. 
• Previous experience of a technology transfer in a cell culture capacity is advantageous.
• In-depth technical and operational knowledge of multiple unit operations in cell culture processing, centrifugation, depth filtration. 
• Understanding of cause and effect of cell culture metabolism, or downstream processing with chromatography, UFDF, viral filtration and sub-micron filtration, pH adjustment and final fill.
• Strong understanding of technology transfer, bioreactor scale-up process or scaling principles for downstream unit operations.
• Experience of Validation / Verification of GMP equipment or processes would be beneficial.
• Experience of process/facility fit, design, commissioning and start-up of a bulk drug substance facility is beneficial.

To discuss this role further contact Graham Cullen on 01 466 1759.

DPS Engineering is an Equal Opportunities Employer.

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