Process Engineer II

The Process Engineer II will be heavily involved in managing the manufacturing and production systems for Viral Vector, Testing, and Technical Development operations. They will provide technical and subject matter expertise in facility design, equipment design and process integration, utility design, and regulatory compliance for engineering matters.

• Own and support process equipment and utility systems, including troubleshooting, process improvements, maintenance strategies, and on-call support.
• Lead technical activities related to SOP changes, deviations, investigations, CAPAs, and equipment corrective/preventive actions.
• Serve as engineering lead for client projects, technology transfers, equipment evaluations, and process/system modifications.
• Manage engineering design, installation, commissioning, qualification, and lifecycle activities while coordinating with vendors, contractors, and cross-functional teams.
• Define project scope, lead small capital projects, and drive remediation of operational and engineering issues.

• Author, review, and approve engineering specifications, standards, protocols, and manufacturing documentation.
• Maintain and update engineering drawings, P&IDs, automation documentation, and equipment/facility records.
• Ensure engineering documentation is accurate, accessible, and compliant within document management systems.
• Own engineering design and process standards and support special projects as needed.

• B.S. or M.S. in Engineering or a Life / Physical Science with relevant work experience (Chemical Engineering or Mechanical Engineering preferred, others considered)
• 3+ years experience investigating, developing, and implementing new manufacturing processes and improving existing manufacturing processes
• Working knowledge of design specification and operation of bioprocess equipment, clean utilities, GMP facilities, and automation.