Senior Principal Aseptic Filling Systems Engineer

Johnson & Johnson Innovative Medicine; Wilson (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Wilson, NC seeks a Sr. Principal Process Engineer to lead aseptic filling line projects.

You will own end-to-end design, qualification, and start‑up of state‑of‑the‑art filling systems for vials and prefilled syringes within a new cGMP facility. Join a Global Process Engineering team to drive technical leadership, vendor coordination, and cross‑functional collaboration with Manufacturing, MSAT, Quality, and EHS, delivering compliant, high‑performing

Qualifications

• Bachelor's Degree in engineering required.
• 10+ years of process engineering & capital projects experience in aseptic filling for biologics.

Responsibilities

• Lead the development and delivery of aseptic filling line system documentation (URS, data sheets, P&IDs, PFDs).
• Evaluate and select equipment vendors; maintain filling system performance during project execution.
• Lead design and engineering of aseptic filling lines (e.g., E‑Beam, isolators) with suppliers and cross‑functional teams.
• Own layout and integration of filling line within facility; ensure alignment with Annex 1 and regulatory needs.
• Lead FAT/SAT, C&Q, and start‑up of aseptic filling systems.
• Drive issue resolution during C&Q and start‑up; ensure readiness for qualification and operation.
• Coordinate across Manufacturing, Facilities, MSAT, Quality, Procurement, EHS to maintain momentum.
• Provide technical leadership and partner management across evolving business and regulatory expectations.
• Stay ahead of industry trends and regulatory changes; benchmark against standards.
• Apply data‑driven insights to inform technical decisions and portfolio strategy.
• Ensure compliance with cGMP, global standards, and customer specifications.

Skills

Aseptic filling

Capital project leadership

Regulatory compliance (FDA cGMPs)

Cross-functional leadership

Education

Bachelor's Degree in Engineering

Tools

URS & PFDs

P&IDs

Job description

Johnson & Johnson Innovative Medicine in Wilson, NC seeks a Sr. Principal Process Engineer to lead aseptic filling line projects.

You will own end-to-end design, qualification, and start‑up of state‑of‑the‑art filling systems for vials and prefilled syringes within a new cGMP facility. Join a Global Process Engineering team to drive technical leadership, vendor coordination, and cross‑functional collaboration with Manufacturing, MSAT, Quality, and EHS, delivering compliant, high‑performing