This role leads the site-wide media fill program to ensure the highest standards of sterility assurance and regulatory compliance
Job Summary
This role leads the site-wide media fill program to ensure the highest standards of sterility assurance and regulatory compliance.
The position requires deep technical leadership in aseptic processing, contamination control strategies, and cleanroom operations.
Candidates will serve as a Subject Matter Expert during client visits, audits, and regulatory inspections while driving continuous improvement initiatives.
Matching Summary
This role leads the site-wide media fill program to ensure the highest standards of sterility assurance and regulatory compliance.
Skills & Requirements
Must-have
Aseptic process simulation program leadership
GMP and Annex 1 regulatory compliance
Contamination control strategy expertise
Equipment requalification oversight
Deviation investigation and CAPA execution
Nice-to-have
Client-facing CDMO environment experience
TrackWise, SAP, or MES system proficiency
Cross-functional stakeholder influence skills
Continuous improvement culture mindset
Key Requirements
Bachelor's degree in Chemistry, Biology, Biochemistry, Engineering, or related field
10+ years pharmaceutical or biotech manufacturing experience
5+ years leadership and people management experience
Strong experience with FDA and EMA regulatory expectations
Must be legally authorized to work in the United States without sponsorship
Work Rights
Must be legally authorized to work in the US without sponsorship