Support the daily operation and continuous improvement of Pharco's sterile injectables fill-finish lines. Working within an FDA-inspected, aseptic manufacturing environment, you will troubleshoot process deviations, drive OEE improvements, and ensure full GMP compliance.
Key Responsibilities
Oversee fill-finish operations for liquid vials, ampoules, and lyophilised products
Investigate process deviations and implement CAPA with root-cause analysis
Collaborate with QA on batch record review and release documentation
Support equipment qualification (IQ/OQ/PQ) and annual product reviews
Identify and lead Lean/Six Sigma improvement projects on the production floor
Requirements
B.Sc. in Pharmaceutical Engineering, Chemical Engineering, or equivalent
3+ years in sterile pharmaceutical manufacturing
Hands-on experience with aseptic filling equipment and isolator technology
Solid understanding of cGMP, FDA 21 CFR Part 211, and EU Annex 1