Biopharma GMP Process Engineering Leader

BioSpace; City of Troy (NY); On-site; USD 88,000 - 169,000; Full time

Job summary

Regeneron is seeking a Senior Project Engineer to join our Project Engineering team in Troy, NY. You will design, specify, and commission process equipment and clean utilities, leading start-up, commissioning, and site acceptance activities.

The role requires a Bachelor's degree in Chemical/Biochemical Engineering and 5+ years of project or process engineering experience. You will supervise contractors, develop PFDs and P&IDs, and ensure cGMP compliance across manufacturing processes.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related field with 5+ years of project/process engineering experience for Senior level.
• Experience with cGMP process equipment design and sanitary equipment design requirements.
• Strong ability to plan, track, and execute project activities and schedules.

Responsibilities

• Design and specify cGMP process equipment, piping, and controls, including engineering documentation.
• Manage mid-to-large projects for process equipment and clean utilities, including start-up, commissioning, and site acceptance.
• Lead design review and installation of equipment.
• Prepare piping and instrumentation diagrams and develop Process Flow Diagrams.
• Support QA/Validation with design documents and protocol execution.
• Investigate process equipment, utility, and control system anomalies, implementing corrective and preventive actions.
• Supervise mechanical, electrical, and automation contractors.

Skills

Process equipment design

Project management

cGMP knowledge

Sanitary equipment design

Cross-cultural communication

Education

Bachelor's degree in Chemical/Biochemical Engineering

Job description

Regeneron is seeking a Senior Project Engineer to join our Project Engineering team in Troy, NY. You will design, specify, and commission process equipment and clean utilities, leading start-up, commissioning, and site acceptance activities.

The role requires a Bachelor's degree in Chemical/Biochemical Engineering and 5+ years of project or process engineering experience. You will supervise contractors, develop PFDs and P&IDs, and ensure cGMP compliance across manufacturing processes.