Sr. Principal Process Engineer – Packaging

About the role

The Sr. Principal Process Engineer – Packaging will serve as the technical authority for packaging equipment in large‑molecule, aseptic biotherapeutic manufacturing. You will own end‑to‑end process engineering from concept through commercial start‑up.

Key responsibilities

• Develop and deliver packaging specifications, drawings, P&IDs and PFDs for biotherapeutic drug product operations.
• Provide system ownership and technical leadership for packaging equipment, including vendor assessment, bid review, and project execution.
• Lead detailed design, FAT, SAT, commissioning, qualification and commercial line start‑up.
• Resolve complex technical and regulatory issues during C&Q and ensure readiness for commercial operation.
• Partner with Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS and EHS to align priorities and accelerate execution.

Required profile

• Minimum Bachelor’s in Engineering (Mechanical preferred); MS or MBA a plus.
• At least 10 years of packaging equipment process engineering or capital project experience in large‑molecule biotherapeutics.
• Proven ability to lead multicultural, remote teams and manage external partners.
• Experience with serialization, aggregation and greenfield/brownfield GMP aseptic facility start‑ups.

Required skills

• cGMP requirements for biotherapeutic packaging equipment.
• Serialization and aggregation processes for finished drug products.
• EHS‑by‑design and construction safety standards.
• FAT, SAT, commissioning and qualification of aseptic equipment.
• Engineering design tools for P&ID and PFD creation.