Sr. Principal Engineer, Equipment Preparation Lead

Job Function

Process Engineering

Process Engineering

Scientific/Technology

Wilson, North Carolina, United States of America

As part of the Global Process Engineering team, the Sr. Principal Engineer, Equipment Preparation Lead, is the technical subject‑matter expert in the equipment preparation area (parts prep, autoclaves, parts washers, COP/SOP, filter integrity testing). The role is accountable for end‑to‑end process engineering leadership in the design and execution of the equipment preparation area for a new cGMP drug product manufacturing plant, leading commissioning and qualification activities, line start‑up, and ensuring full regulatory compliance.

• Develop and deliver the equipment preparation area system specifications, drawings, user requirements, data sheets, technical specifications, P&IDs, and PFDs.
• Assess vendor competency, review bid documents, and oversee project development and execution, including performance of the process systems.
• Lead the detailed design and development of the equipment preparation area in collaboration with a cross‑functional team including strategic equipment vendors.
• Lead equipment FAT, SAT, C&Q, and start‑up.
• Resolve technical issues on the system during C&Q testing and ensure readiness for C&Q activities.
• Identify and expedite key activities across multiple business functions:
  Manufacturing, Facilities, MSAT, Quality, Procurement, Engineering & Property Services, and EHS.
• Maintain alignment across evolving business needs and demonstrate strong partner management and leadership skills.
• Stay informed on industry trends and benchmark against internal and external practices.
• Apply data‑driven insights and market intelligence to advise future decision‑making and adapt strategies to achieve excellent portfolio performance.
• Ensure compliance with policies, procedures, government regulations, and customer specifications.

• Minimum of a Bachelor’s Degree in engineering; MS or MBA preferred.

• Minimum of 10 years experience in process engineering or capital project execution of equipment preparation equipment (autoclaves, parts washers, filter integrity testing, COP, SOP, equipment disassembly and assembly).
• Track record of developing and maintaining strong partnerships with key stakeholders.
• Ability to lead and motivate multicultural teams and remote customers.
• Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize, and execute project plans as the system SME.
• Excellent problem‑solving skills for handling potential conflicts.
• Understanding of sophisticated technical/regulatory issues impacting facility/equipment design.

• cGMP requirements for aseptic manufacturing across regulatory bodies (EU, FDA), including new EU Annex 1 guidelines.
• Environmental, Health, and Safety (EHS) requirements with a focus on EHS by design and construction safety.
• Start‑up processes and commissioning & qualification of equipment preparation equipment.
• Principles for engineering design for drug products in the biotherapeutic industry.
• Construction and procurement processes.
• Project controls processes and project scheduling.
• Strong technical process engineering knowledge and expertise in solving complex technical problems.
• Strong communication, decision‑making, and problem‑solving skills to drive impact in a fast‑paced business environment.
• Capacity to drive process engineering innovation for equipment and facilities, maintaining and expanding technical knowledge within the team.

• Consistent track record of leading capital projects for aseptic processing equipment, including autoclaves, parts washers, filter integrity units, and COP/SOP systems.
• Capital project leadership of aseptic manufacturing equipment, green or brown‑field GMP manufacturing facility start‑up, in the $100‑$500 MM range.
• Strong process engineering expertise from conceptual design through C&Q to ensure operational readiness within a biotherapeutic drug product environment in filling systems.
• Experience in green or…