Sr. Principal Engineer, Equipment Preparation Lead

Sr. Principal Engineer, Equipment Preparation Lead

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 overall end‑to‑end process engineering leadership in the design and execution of the equipment preparation area for a new cGMP drug product manufacturing plant.

Responsibilities include leveraging scientific, technical, and business expertise to develop system equipment, solve sophisticated technical issues, optimize the process, lead commissioning and qualification activities, and ensure full compliance with regulatory standards.

• Development and delivery of the equipment preparation area system specifications, and drawings (user requirements, data sheets, technical specifications, P&IDs, PFDs)
• Assess vendor competency and capabilities, review and discuss bid documents, and be held accountable for project development and execution, including performance of the process systems
• Lead the detailed design and development of the equipment preparation area collaborating with a diverse multi‑functional team including strategic equipment vendors
• Lead equipment FAT, SAT, C&Q, and start‑up
• Technical issue resolution on the system during C&Q testing and readiness of the system to start C&Q activities
• Helping to 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 require strong partner management and leadership skills to collaborate across these multiple business partners
• Maintain a solid understanding of industry trends and benchmarking against internal/external practices
• Apply data‑driven insights and market intelligence to advise future decision making, stay informed on industry and regulatory trends, and adapt strategies accordingly to achieve excellent portfolio performance
• Ensure compliance with policies, procedures, government regulations, and customer specifications

Wilson, North Carolina, United States of America

• This position will be located in Wilson, North Carolina, and will require full‑time on‑site support. However, the design of the facility will occur at an engineering firm with frequent travel (over 75%) required until the project shifts to the plant site of Wilson, NC.

Education:

Minimum of a Bachelor's Degree in engineering required; MS or MBA preferred.

Required:

• Minimum of 10 years experience in process engineering or capital project execution of equipment preparation equipment – autoclaves, parts washers, filter integrity testing, COP (clean‑out‑of‑place), SOP (steam‑out‑of‑place), 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 filling system SME
• Excellent problem‑solving skills when handling potential conflicts
• Understanding sophisticated technical/regulatory issues impacting facility/equipment design

Solid understanding of the following:

• cGMP’s for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment design
• EHS requirements, with particular focus on EHS by design and construction safety
• Start‑up processes and Commissioning & Qualification of equipment preparation equipment (autoclaves, parts washers, filter integrity test stations, COP/SOP stations)
• Principles for engineering design for drug products in the biotherapeutic industry
• Construction & Procurement process
• Project Controls processes
• Project scheduling
• Strong technical process engineering knowledge and experience and a passion for solving highly complex technical problems
• Strong problem solving, communication, and decision‑making…