Senior Lead Process Engineer

Senior Principal Process Engineer – Aseptic Bio therapeutic Filling Equipment

Wilson, North Carolina (On-site) | Significant travel during project phase

Blackfield Associates are supporting a leading biopharmaceutical manufacturer, who due to project demands are seeking a Senior Principal Process Engineer to provide technical leadership for the design, implementation, commissioning, qualification, and start-up of next-generation aseptic filling systems supporting a major cGMP manufacturing facility.

This is a high-impact SME role responsible for delivering vial and pre-filled syringe filling technologies, isolators, E-beam systems, and associated aseptic processing equipment from concept through commercial readiness.

Key Requirements

• 10 years' experience in aseptic filling process engineering and/or capital project delivery within a biopharmaceutical manufacturing environment
• Expertise in sterile injectable biologics, including monoclonal antibodies, recombinant proteins, vaccines, or related products
• Proven experience leading design, installation, commissioning, qualification (C&Q), and start-up of aseptic filling lines and isolator-based technologies
• Strong knowledge of FDA cGMP regulations, EU GMP Annex 1, contamination control strategies, and aseptic processing
• Experience managing major equipment vendors, engineering partners, and cross-functional stakeholders
• Demonstrated success delivering complex capital projects, ideally within greenfield or brownfield manufacturing facilities

Preferred:

• Experience leading aseptic filling projects valued at $50M-$80M
• Strong technical leadership and stakeholder management skills
• Bachelor's degree in Engineering (Mechanical preferred); advanced degree advantageous

This is an outstanding opportunity to play a key role in developing a world-class biopharmaceutical manufacturing operation and shaping the future of sterile drug product manufacturing.

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