Senior Process Engineer

Senior Process Engineer – Biotech Facility Expansion

Location: Holly Springs, NC

Duration: 12 Months onsite

**Only W2/1099 - No C2C**

This role supports a brownfield biotech facility expansion, focusing on cGMP bulk drug substance manufacturing. The Senior Process Engineer will be responsible for technical deliverables throughout the detailed design, construction management, commissioning, and startup phases. This role requires close collaboration with Engineering, Manufacturing, Facilities, Quality, and Validation teams to ensure successful implementation, qualification, and operational readiness of equipment, systems, and processes.

Key Responsibilities:

• Serve as the SME for upstream and downstream manufacturing systems, addressing technical inquiries from the A/E firm and client.
• Act as the primary interface for process-related technical aspects, liaising with the Engineering & Procurement (EP) Services provider.
• Define and ensure adherence to process technical expectations, standards, and guidelines.
• Lead and participate in all phases of engineering projects, including conceptual and detailed design, procurement, installation, commissioning, validation, and qualification.
• Review design drawings, P&IDs, and system layouts for accuracy and compliance.
• Oversee contractors and equipment vendors to ensure project milestones are met within scope, budget, and schedule.
• Identify and mitigate project risks using structured risk management approaches.
• Conduct hands-on activities, including drafting procedures and executing commissioning/startup studies.
• Troubleshoot process deviations, failures, and inefficiencies.
• Provide engineering support for CQV activities related to bioreactors, chromatography skids, filtration systems, and support utilities.
• Support FAT, SAT, and commissioning efforts for process equipment.
• Work closely with project engineers, contractors, and vendors to execute system upgrades while minimizing impact on operations.
• Manage change control processes for process modifications and equipment upgrades.
• Oversee punch list resolution and provide post-installation support.
• Ensure compliance with EH&S regulations and safety best practices.
• Confirm operational readiness before transitioning systems to Manufacturing and Maintenance teams.

Qualifications & Experience:

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related discipline.
• 10–15 years of experience in GMP/life sciences/pharmaceutical manufacturing.
• Hands-on experience with upstream and downstream processing equipment, including bioreactors, chromatography skids, depth filtration, TFF, and UF/DF.
• Strong knowledge of bioprocessing, aseptic processing, and cell therapy manufacturing.
• Expertise in troubleshooting bioprocess deviations and equipment performance issues.
• Familiarity with GMP, cGMP, ISPE guidelines, and regulatory compliance requirements.
• Ability to work in a fast-paced, cross-functional environment while managing multiple priorities.
• Experience collaborating with facilities, operations, vendors, and engineering consultants.