Principle Process Engineer

Blackfield Associates are currently partnered with a global pharmaceutical manufacturer to support their search for a Principle Process Engineer to join their project based in North Carolina on a fulltime permanent basis.

Key Responsibilities

• Provide technical leadership for the design, implementation, commissioning, qualification, and start-up of aseptic drug product manufacturing systems, including compounding, equipment preparation, and aseptic filling operations.
• Lead the development of engineering deliverables, including user requirements specifications, process flow diagrams, P&IDs, equipment data sheets, and technical specifications.
• Oversee the design and integration of aseptic drug product systems, including filling lines, isolators, compounding equipment, single-use technologies, autoclaves, parts washers, filter integrity testing systems, and cleaning and sterilization equipment.
• Evaluate and manage equipment vendors, engineering partners, and contractors throughout design, procurement, installation, and start-up activities.
• Lead FAT, SAT, commissioning, qualification, and operational readiness activities to ensure systems are delivered safely, compliantly, and fit for purpose.
• Drive technical troubleshooting and resolution of complex equipment, process, and regulatory challenges during project execution and start-up.
• Coordinate activities across Manufacturing, MSAT, Quality, Facilities, Procurement, Engineering, Construction, and EHS teams to ensure alignment and project success.
• Ensure compliance with cGMP requirements, FDA regulations, EU Annex 1 guidance, contamination control strategies, and company quality standards.
• Support project controls, scheduling, procurement, and construction activities to maintain progress against project milestones.
• Drive continuous improvement and innovation by applying industry best practices, emerging technologies, and benchmarking insights to process and equipment design.

Experience Required

• Bachelor’s degree in Engineering, preferably Mechanical or Chemical Engineering. Advanced degree preferred.
• Sufficient experience in process engineering and capital project delivery within aseptic biopharmaceutical or drug product manufacturing environments.
• Proven experience leading the design, installation, commissioning, qualification, and start-up of aseptic drug product manufacturing systems.
• Strong expertise in aseptic filling operations, aseptic compounding processes, equipment preparation systems, and contamination control strategies.
• Hands-on experience with filling lines, isolators, single-use technologies, compounding systems, autoclaves, parts washers, COP/SOP systems, and filter integrity testing equipment.
• Deep understanding of FDA cGMP regulations, EU Annex 1 requirements, commissioning and qualification methodologies, and aseptic manufacturing principles.
• Experience managing equipment vendors, engineering firms, construction contractors, and multidisciplinary project teams on large capital projects.
• Strong knowledge of pharmaceutical facility design, project controls, procurement processes, construction execution, and operational readiness planning.
• Proven ability to solve complex technical challenges, lead cross-functional teams, and drive projects through all phases of execution.
• Experience supporting greenfield or brownfield biopharmaceutical facility projects is highly desirable.
• Previous experience delivering large-scale aseptic manufacturing capital projects and transitioning systems from design through commercial operation is preferred.