Sr. Principal Engineer, Equipment Preparation Lead

About the role

The Sr. Principal Engineer, Equipment Preparation Lead will serve as the technical subject matter expert for equipment preparation (autoclaves, parts washers, filter integrity testing, COP/SOP) in a new cGMP drug product manufacturing plant. This role drives design, execution, commissioning and qualification of the equipment preparation area while ensuring regulatory compliance.

Key responsibilities

• Develop and deliver system specifications, drawings, P&IDs and PFDs for the equipment preparation area.
• Assess vendor competency, lead equipment FAT, SAT, commissioning & qualification, and support start‑up activities.
• Lead detailed design with cross‑functional teams and manage project execution across manufacturing, facilities, quality, procurement and engineering services.
• Resolve technical issues during C&Q testing and ensure readiness for line start‑up.

Required profile

• Minimum Bachelor’s degree in engineering (MS or MBA preferred) with at least 10 years of process engineering or capital project experience in equipment preparation.
• Proven ability to lead multicultural teams, manage external partners and drive complex capital projects in aseptic GMP environments.
• Strong understanding of cGMP regulations (EU, FDA), EU Annex 1, EHS by design and construction safety.

Required skills

• Autoclaves, parts washers, filter integrity testing, COP and SOP equipment.
• cGMP compliance, EU Annex 1 guidelines.
• EHS requirements, commissioning & qualification processes.
• Process engineering, project scheduling and controls.