Sr. Principal Engineer, Aseptic DP Compounding Owner

About the role

The Sr. Principal Engineer will serve as the technical subject matter expert for aseptic biotherapeutic drug product compounding, leading end‑to‑end process engineering for design, execution and start‑up of compounding suites.

Key responsibilities

• Develop and deliver equipment specifications, drawings, user requirements, data sheets, P&IDs and PFDs for single‑use mixers, stainless‑steel tanks, COP and SOP skids, mixing and filter integrity testing.
• Lead detailed design, vendor assessment, FAT, SAT, commissioning & qualification (C&Q) and start‑up of two aseptic DP compounding suites, collaborating with multi‑functional teams and external partners.
• Resolve technical issues during C&Q, ensure regulatory compliance, and align project activities across manufacturing, facilities, quality, procurement and engineering services.

Required profile

• Minimum Bachelor’s in engineering (Chemical preferred); MS or MBA a plus.
• At least 10 years experience in aseptic drug product compounding in a cGMP biotherapeutics environment.
• Proven track record leading capital projects, designing single‑use technology and stainless‑steel tank cleaning/sterilization recipes.

Required skills

• Single‑use technology design (mixers, product fluid path).
• Stainless‑steel tank design, cleaning and sterilization.
• cGMP compliance for biotherapeutic DP aseptic compounding.
• FAT, SAT, commissioning & qualification procedures.
• P&ID and PFD development.