Process Engineer, Upstream

A leading biopharmaceutical facility-set to become the largest of its kind globally-is seeking a Process Engineer to support upstream operations for a high-impact startup initiative. This role will be instrumental in launching a 20,000-liter bioreactor system and supporting the facility's first GMP production run. The Process Engineer will collaborate across engineering, quality, and maintenance teams to ensure process readiness, equipment verification, and operational excellence.

This position will follow standard hours: Monday through Friday, 8:00 AM to 5:00 PM, onsite in Holly Springs, NC.

Responsibilities for the Process Engineer include:

• Upstream Process Execution & Support:

• Manage operations from vial file thaw to harvest, ending before the first chromatography column.

• Support Performance Qualification (PQ) activities, including sterility holds and shake-down completion.

• Collaborate with engineers across media prep, seed, cell culture, and harvest to ensure seamless process flow.

• CQV & Equipment Readiness:

• Execute final verifications and modifications for brand-new equipment.

• Partner with Quality and Maintenance teams to ensure equipment and systems are ready for production.

• Assist in documentation and troubleshooting during startup and initial runs.

• Startup & On-Floor Support:

• Provide hands-on support during the first production run in October.

• Contribute to real-time problem-solving and process optimization.

• Participate in continuous improvement initiatives to enhance operational efficiency.

Requirements for the Process Engineer include:

• Bachelor's degree in Engineering or related technical field (preferred).
• 8-10 years of upstream biomanufacturing experience.
• Strong background in manufacturing support (not just CQV).
• Proven ability to coordinate process modifications and drive execution.
• Experience in startup environments highly preferred.
• Strong analytical, problem-solving, and organizational skills.
• Ability to thrive in a fast-paced, execution-heavy environment.

Compensation for the Process Engineer includes:

• Salary Range: $80-90/hr
• Benefits: Full suite including medical, dental, vision, 401(k), PTO, holidays, and sick leave as required by law

Keywords:

Process Engineer, Upstream Biomanufacturing, CQV, PQ, Sterility Holds, Bioreactor Startup, Depth Filtration, Chromatography, GMP Manufacturing, Equipment Verification, Process Optimization, Technical Documentation, Quality Compliance

Application Start Date: August 11, 2025

Application Window: Open for a minimum of 30 days from posting

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