Project Engineer Consultant New

Project Engineer Consultant (Process Engineering)

Process Engineer providing technical process design and delivery support for bioprocess systems on a new CAPEX process area project. Responsible for system design, vendor oversight, testing, and commissioning through the full project lifecycle.

• Generation of User Requirement Specifications (URS) for assigned process systems
• Review and approval of Basis of Design and detailed design documentation including PFDs, P&IDs, layouts, and models
• Review of procurement packages including BOMs, datasheets and vendor documentation to ensure compliance with Regeneron specifications
• Tracking of HAZOP actions and confirmation that safety actions are incorporated into system design
• Participation in 30%, 60% and 90% model reviews to ensure operational, safety, and ergonomic requirements are met
• Review and approval of system lifecycle documentation including Functional Specifications, Software Design Specifications and IO lists
• Attendance and support of equipment FATs and automation software bench FATs as required
• Execution and supervision of SAT, commissioning, and start-up activities
• Generation and execution of FAT, SAT and commissioning protocols in line with Regeneron standards
• Management of Vendor Document Requirements and documentation completeness
• Development of preventative maintenance tasks and spare parts lists within the CMMS

• Bachelor’s degree in Chemical, Process or Mechanical Engineering, or equivalent relevant experience
• Three to five years’ experience in biopharmaceutical process engineering environments
• Experience supporting design, installation, commissioning and qualification of bioprocess equipment
• Strong understanding of GMP, safety studies and lifecycle documentation
• Experience working with automation systems desirable, including DeltaV
• Ability to work as system owner within a multi-disciplinary CAPEX project team

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