Process Engineer (Fill Finish) Contract Opportunity
LSC is offering a contract opportunity for a Process Engineer (Fill Finish) to join our Cork-based biopharmaceutical company.
The site manufactures low-volume bulk API for Phase III clinical trials, initial product launch, and long-term market support.
The team on-site 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 daily 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 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: If you are currently eligible to work in Ireland, you will need to hold a Stamp 1 G/Stamp 4 visa to apply.
Work from home benefits available.
Apply via this advert or contact Adam Murphy at LSC for more information about this opportunity.
Required skills: Fill Finish, Drug Product Process Improvements.