This role offers a high-impact opportunity to shape aseptic standards and mentor operations personnel within a dynamic, multi-product vaccine manufacturing environment
Job Summary
This role offers a high-impact opportunity to shape aseptic standards and mentor operations personnel within a dynamic, multi-product vaccine manufacturing environment.
The successful candidate will serve as the Subject Matter Expert for site sterility assurance, driving compliance with EU GMP Annex 1 and cGMP requirements while leading microbial investigations.
As the site owner of the Environmental Monitoring Program, you will collaborate with Quality, Validation, and Operations teams to ensure inspection readiness and operational efficiency.
Matching Summary
This role offers a high-impact opportunity to shape aseptic standards and mentor operations personnel within a dynamic, multi-product vaccine manufacturing environment.
Skills & Requirements
Must-have
10+ years biopharma industry experience
Bachelor's degree in microbiology
Expertise in EU GMP Annex 1 requirements
Environmental monitoring program ownership
Root cause analysis and risk management
Nice-to-have
Strong written and verbal communication
Experience with technical document review
Mentoring operations personnel skills
Strategic continuous improvement mindset
Global audit inspection readiness
Key Requirements
Bachelor's degree in microbiology or relevant discipline
10+ years of experience in Biopharma/Pharma Industry
Proven expertise in sterile manufacturing and facility design