Process Equipment Engineer

Help Build the Future of Biologics Manufacturing

We are seeking experienced Upstream Process Equipment Engineers to support a major biologics manufacturing expansion project in Holly Springs, NC. This is an exceptional opportunity to play a key role in bringing large-scale upstream manufacturing systems from equipment turnover through startup, qualification, and commercial operations.

If you thrive in fast-paced GMP environments, enjoy hands‑on engineering work, and want to make a direct impact on manufacturing readiness and operational success, this role is for you.

• Serve as the engineering owner for critical upstream process equipment.
• Lead equipment turnover, mechanical completion verification, startup, commissioning, and qualification activities.
• Perform P&, redlines, and field verification.
• Coordinate with equipment vendors, construction teams, CQV personnel, and manufacturing operations.
• Participate in FATs, SATs, engineering runs, and troubleshooting efforts.
• Support PPQ and commercial manufacturing campaigns.
• Conduct equipment-related risk assessments and support change control activities.
• Investigate equipment issues, deviations, and operational challenges while driving CAPA implementation.
• Support campaign changeovers and ongoing process improvements.
• Assist with LOTO identification and equipment safety initiatives.

• Media and buffer preparation systems
• Depth filtration systems
• Related process piping and manufacturing equipment

• 5+ years of experience in biopharmaceutical or biologics process/equipment engineering.
• Experience serving as a responsible engineer or equipment owner in a GMP manufacturing facility.
• Hands‑on experience supporting startup, commissioning, CQV, FAT/SAT, and operational readiness activities.
• Strong understanding of P&IDs, field walkdowns, and redlining practices.
• Experience with deviations, investigations, CAPA, change control, and risk assessments.
• Knowledge of stainless‑steel process equipment and upstream manufacturing operations.
• Proven ability to work cross‑functionally with engineering, operations, quality, and validation teams.

• Experience with monoclonal antibody (mAb) manufacturing.
• Experience in large‑scale biologics drug substance facilities.
• Navisworks or other 3D model review experience.
• LOTO procedure development and implementation experience.
• Familiarity with major upstream equipment vendors and OEMs.

• Be part of a highly visible, large‑scale biologics manufacturing expansion.
• Own critical process systems from startup through commercial production.
• Work alongside industry‑leading engineering, CQV, and manufacturing professionals.
• Gain hands‑on experience with advanced upstream technologies and equipment.
• Contribute directly to the successful launch and operation of a world‑class manufacturing facility.

If you’re an experienced equipment engineer who enjoys solving complex technical challenges and driving manufacturing success, we’d love to connect with you.