LSC have a great contract opportunity for Process Engineer to join a 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 grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities.
- Required to review all packaging component designs/specifications as part of change control to ensure Design for Manufacture (DFM) and liaise with central Artwork Team/Packaging Development Team for any required alterations.
- Required to maintain process equipment recipes through coordination with the site engineering functions and change control.
- Required to manage and execute changes to all variable batch data printing equipment across the manufacturing site packaging lines.
- Required to ensure relevant metrics for equipment performance are effectively monitored and reported out on a weekly basis.
- Required to create, obtain approval, and publish technical documentation through Document Management system supporting process development studies.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 2-3 years' experience of operations and/or manufacturing engineering within a regulated environment (Pharmaceutical /Medical Device)
- Other continuing education initiatives desirable - Six Sigma, Lean Manufacturing, industry specific coursework
- Strong in Upstream (Bioreactors, IUF etc), Downstream (Chromatography) and Support Services (Autoclaves and Partswashers).
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Adam Murphy at LSC on 021-4777329 if you have any more questions about this opportunity!