Sr. Principal Engineer, Equipment Preparation Lead

Sr. Principal Engineer, Equipment Preparation Lead

Location:

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.

• Development and delivery of the equipment preparation area system specifications and drawings (user requirements, data sheets, technical specifications, P&IDs, PFDs).
• Assessment of vendor competency and capabilities, review and discussion of bid documents, and accountability for project development and execution, including process system performance.
• Lead detailed design and development of the equipment preparation area in collaboration with a diverse multi‑functional team, including strategic equipment vendors.
• Lead equipment FAT, SAT, C&Q, and start‑up activities.
• 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, E&PS, and EHS).
• Ensure alignment across evolving business needs and demonstrate strong partner management and leadership skills.
• Maintain a solid understanding of 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 industry and regulatory changes.

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

• At least 10 years of 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 engage remote customers.
• Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize, and execute project plans as a system SME.
• Excellent problem‑solving skills when handling potential conflicts.
• Deep understanding of sophisticated technical and regulatory issues impacting facility and equipment design.
• Solid knowledge of cGMP requirements for aseptic manufacturing across multiple regulatory bodies (EU, FDA) and fluency in new EU Annex1 guidelines.
• Experience with EHS requirements, focusing on EHS by design and construction safety.
• Proficiency in start‑up processes and commissioning & qualification of equipment preparation equipment.
• Principles for engineering design of drug products in the biotherapeutic industry.
• Knowledge of construction and procurement processes.
• Project controls and scheduling expertise.
• Strong technical process engineering knowledge and a passion for solving complex technical problems.
• Strong communication and decision‑making skills to drive impact in a fast‑paced environment.
• Ability to drive process engineering innovation for equipment and facilities, ensuring technical knowledge is maintained and expanded throughout the team.

• Consistent track record leading capital projects for aseptic processing equipment (autoclaves, parts washers, filter integrity units, COP/SOP systems).
• Leadership of capital projects for aseptic manufacturing equipment and green or brown‑field GMP manufacturing facility start‑ups in the $100–$500MM range.
• Expertise in conceptual design through C&Q to ensure efficient operational readiness within a biotherapeutic drug product environment.
• Experience in green or brown‑field GMP manufacturing facility start‑ups.

This position will be located in Wilson, North Carolina, and will require full‑time on‑site support. The facility design will occur at an engineering firm, with frequent travel (>75%) required until the project moves to…