Biopharma Process Engineering Lead – CMO Projects

Socket.dev; United States; On-site; USD 88,000 - 144,000; Full time

Job summary

Regeneron seeks an experienced Project Engineer to join our Engineering team, supporting the CMO network. You will design, specify, and commission biopharmaceutical process equipment, renovate systems, and provide engineering support at contract manufacturing facilities.

The role requires a Bachelor's in Chemical Engineering and 5+ years in project/process engineering with a focus on biopharma equipment, automation, and documentation. On-site in Troy, NY with up to 25% travel.

Qualifications

• Bachelor's degree in Chemical Engineering or a related discipline.
• 5+ years of experience in project/process engineering.
• Direct experience with biopharmaceutical process equipment is preferred.
• Strong understanding of process control systems and automation.
• Experience planning and tracking project activities and schedules.

Responsibilities

• Design and specify cGMP process equipment, piping, and controls; including development and review of engineering documentation.
• Manage small-to-mid sized projects related to process equipment and clean utilities, including start-up and commissioning.
• Lead design review, site acceptance, and installation of equipment.
• Prepare P&ID and Process Flow Diagrams for manufacturing processes.
• Support QA/Validation by preparing design documents and protocol execution.
• Investigate anomalies and safety incidents; implement corrective actions.
• Prepare and execute change controls; provide engineering evaluation and test plans.
• Supervise contractors for mechanical, electrical, and automation work.
• Procure equipment and services; negotiate with suppliers.
• Provide engineering support for equipment at contract manufacturing facilities.

Skills

Project management

Process equipment design

cGMP/compliance

Automation/controls

Communication

Education

Bachelor's degree in Chemical Engineering

Job description

Regeneron seeks an experienced Project Engineer to join our Engineering team, supporting the CMO network. You will design, specify, and commission biopharmaceutical process equipment, renovate systems, and provide engineering support at contract manufacturing facilities.

The role requires a Bachelor's in Chemical Engineering and 5+ years in project/process engineering with a focus on biopharma equipment, automation, and documentation. On-site in Troy, NY with up to 25% travel.