Sr. Principal Engineer - Bioprocess

Responsibilities

• Provide Process Engineering support to the Global Facility Delivery team with a strong focus on right first time and on schedule facility start-up (e.g. design reviews, process safety assessments, User Requirements, C&Q support, Unit Operation Shakedown, Facility Run Rate Readiness)
• Define and own relevant aspects of the overall integrated Operational Readiness Plan (e.g. SOP development, maintenance strategy, automation optimization, run rate readiness, MES EBR requirements, alarm requirements, Performance Qualification Study Requirements / Protocol Development etc.)
• Own the Performance Qualification strategy and execution for area of responsibility
• Support initial Operations Training requirements as the Equipment and Area SME Lead/support the tech transfer of new processes into the facility
• Provide process engineering support through application of process engineering fundamentals
• Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team
• Utilise root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions
• Monitor, assess and document equipment performance to maintain ongoing qualification
• Develop and maintain the basis of safety for process equipment
• Develop and implement unit operation and equipment control strategy

Qualifications

• Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline
• 7+ years of process team experience in pharmaceutical manufacturing, preferably monoclonal antibody manufacturing