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.
Responsibilities
- 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
Requirements
- 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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