Not specified (assumed on-site due to manufacturing requirements).
Bachelor's degree preferred
1 year professional experience required
Fda regulated environment experience
American Regent Inc. is seeking a Manufacturing Principal Investigator I to investigate and document non-routine events in the manufacturing of sterile pharmaceuticals. The candidate will work cross-functionally and is expected to maintain production schedules while ensuring compliance with company SOPs and regulations
Job Summary
The Principal Investigator I ensures all non-routine events in sterile pharmaceutical manufacturing are investigated and documented according to cGMPs.
This cross-functional role requires generating investigation summaries, performing root cause analyses, and maintaining production schedules across multiple departments.
Candidates must be physically able to wear cleanroom protective gowning including respirators and face shields to support aseptic manufacturing investigations.
Matching Summary
Match Score: 75
American Regent Inc. is seeking a Manufacturing Principal Investigator I to investigate and document non-routine events in the manufacturing of sterile pharmaceuticals. The candidate will work cross-functionally and is expected to maintain production schedules while ensuring compliance with company SOPs and regulations.
Skills & Requirements
Must-have
Bachelor's degree preferred
1 year professional experience required
FDA regulated environment experience
cGMP manufacturing investigation skills
Intermediate MS Word and Excel skills
Nice-to-have
Experience with MS Visio and Access
Technical writing and problem solving skills
Ability to work independently with minimal supervision
Team oriented work environment
Willingness to work overtime as needed
Key Requirements
Bachelor's degree preferred
Minimum 1 year experience in professional setting
Experience investigating issues in cGMP manufacturing