LSC has an excellent contract opportunity for a Process Engineer (Fill Finish) at a Cork-based biopharmaceutical company.
The site produces low-volume bulk API for Phase III clinical trials, initial product launch, and long-term market support.
The on-site team grows, purifies, formulates, and bulk fills mammalian cell culture-derived APIs for medicines intended for human use.
About the Project - Key Responsibilities:
* Comply with Company Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in day-to-day activities.
* Review all packaging component designs/specifications as part of change control to ensure Design for Manufacture (DFM) and liaise with the central Artwork Team/Packaging Development Team for required alterations.
* Maintain process equipment recipes through coordination with the site engineering functions and change control.
* Create, obtain approval, and publish technical documentation through the Document Management system supporting process development studies.
About You - Are Your Skills a Match?
* 2-3 years' experience in operations and/or manufacturing engineering within a regulated environment (Pharmaceutical/Medical Device)
* Strong knowledge of Fill Finish Operations
* Other continuing education initiatives desirable: Six Sigma, Lean Manufacturing, industry-specific coursework
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1 G/Stamp 4 visa to apply.
Apply via this advert or contact Adam Murphy at LSC if you have any more questions about this opportunity.
Benefits:
* Work From Home