Experteer Overview As Principal Engineer you provide technical leadership for isolated sterile fill finish and lyophilization equipment, guiding front-end designs and cross-functional execution.

You will drive standardization, Lean/CI practices, and capital project governance across integral operations.

Your role shapes site engineering standards, asset planning, and continuous improvement, partnering with senior leadership to align with enterprise priorities.

This is an opportunity to influence high-impact manufacturing programs and advance life-changing therapies.

Compensaciones / Beneficios• Serve as SME for isolated or RABS sterile fill finishing and lyophilization; lead or oversee FEED efforts and project charters.• Manage external engineering partners and internal cross-functional teams to deliver Front End Engineering Designs (FEED) and project baselines.• Develop segment-wide engineering standards and governance to standardize approaches across engineering and facilities teams.• Drive standard work, process documentation,



and continuous improvement within the segment.• Evaluate equipment modifications and new systems for optimal resource use and control; organize project governance and stakeholder communications.• Lead site manufacturing asset assessments and master planning; conduct troubleshooting and technical analyses of equipment/processes.• Prepare URS, risk and safety assessments; oversee design reviews, factory/site acceptance testing, and end-user system requirements.• Foster a culture of Lean Manufacturing and CI; mentor site engineering teams and support safety and regulatory compliance.• Lead major capital projects as needed and provide technical support through gate processes and vendor coordination.

Responsabilidades• BS in Chemical, Mechanical, or other Engineering• PMP certification or equivalent• 15+ years in cGMP engineering/ facilities/ utilities (biotech/pharma/CDMO preferred)• 10+ years in life science CDMO environment• 5+ years people leadership• 5+ years procurement/negotiation and vendor decisions• 5+ years continuous improvement and innovation ideation• Experience in aseptic processing and aseptic liquid filling (vials, cartridges, syringes) with isolation/RABS; aseptic lyophilization; refrigerated/frozen capabilities

Requisitos principales•

📌 Principal Engineer, Global Technical Operations, Engineering & Innovation (León)
🏢 Trustack
📍 León