Senior Validation Specialist – Aseptic Operations

Why this role stands out

• Own the end-to-end APS/media fill program in a commercial aseptic manufacturing environment
• Work on next-generation therapies, including gene therapy and sterile injectables
• Join a collaborative, high-growth team with strong leadership support
• Have direct visibility with Manufacturing, QA, MS&T, and Engineering

What you’ll be doing

• Lead and own aseptic process simulation / media fill activities from planning through execution, reporting, and follow-up
• Develop risk-based APS strategies, including worst-case conditions and interventions
• Author and review media fill protocols, reports, and validation documentation
• Lead deviations, root cause analysis, CAPAs, and revalidation tied to APS/media fills
• Support broader process validation activities, including PPQ/CPV
• Partner cross-functionally to strengthen aseptic operations, compliance, and inspection readiness

What we’re looking for

• 5+ years of validation experience in biologics, sterile manufacturing, or gene/cell therapy
• Direct hands-on APS/media fill experience is required
• Proven ownership of media fill strategy and execution, not just support or review
• Commercial drug product manufacturing experience, not just clinical
• Strong understanding of aseptic processing, contamination control, FDA expectations, and EU GMP Annex 1
• Experience with sterile injectables, isolators, or closed systems preferred
• Able to work independently and influence cross-functional teams