Sr. Principal Engineer, Equipment Preparation Lead (Biopharmaceutical Manufacturing)

Location: Wilson, North Carolina, United States; full-time on-site support required. Frequent travel of more than 75% is required during facility design until the project shifts to the Wilson plant site.

Company

Johnson & Johnson develops healthcare, innovative medicine, and MedTech solutions focused on preventing and treating complex diseases.

What you will do

• Lead end-to-end process engineering for the equipment preparation area of a new cGMP drug product manufacturing plant.
• Develop system specifications, user requirements, data sheets, technical specifications, drawings, P&IDs, and PFDs.
• Lead detailed design, vendor assessment, bid document reviews, equipment FAT, SAT, commissioning, qualification, and start-up.
• Resolve complex technical issues and ensure equipment readiness for commissioning and qualification activities.
• Coordinate Manufacturing, Facilities, MSAT, Quality, Procurement, Engineering & Property Services, EHS, vendors, and external engineering partners.
• Ensure compliance with regulatory standards, government regulations, company policies, and customer specifications.

Requirements

• Bachelor’s degree in engineering required; an MS or MBA is preferred.
• At least 10 years of experience in process engineering or capital project execution involving autoclaves, parts washers, filter integrity testing, COP/SOP, and equipment assembly and disassembly.
• Experience leading equipment preparation systems through design, commissioning, qualification, and start-up.
• Knowledge of cGMP requirements for aseptic manufacturing, EU and FDA regulations, and EU Annex 1 guidance.
• Experience with EHS by design, construction safety, procurement, project controls, scheduling, and biotherapeutic drug product engineering.
• Strong technical problem-solving, communication, decision-making, stakeholder management, and multicultural team leadership skills.

Nice to have

• Experience leading capital projects for aseptic processing equipment.
• Leadership of greenfield or brownfield GMP manufacturing facility start-ups.
• Experience with capital projects valued at $100–$500 million.
• Process engineering experience from conceptual design through commissioning and qualification in a biotherapeutic filling environment.

Culture & Benefits

• Work with a global process engineering organization and multidisciplinary business partners.
• Collaborate with engineering firms, construction companies, equipment vendors, and other external partners.
• Support innovation and continuous development of technical knowledge across the engineering team.
• Participate in an inclusive work environment that respects employee diversity and dignity.