LSC has a great contract opportunity for a Packaging 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 grows, purifies, formulates, and bulk fills mammalian cell culture-derived APIs for medicines intended for human use.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
1. 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.
2. 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 any required alterations.
3. Maintain process equipment recipes through coordination with the site engineering functions and change control.
4. Manage and execute changes to all variable batch data printing equipment across the manufacturing site packaging lines.
5. Ensure relevant metrics for equipment performance are effectively monitored and reported out on a weekly basis.
6. Create, obtain approval, and publish technical documentation through the Document Management system supporting process development studies.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
1. 2-3 years' experience in operations and/or manufacturing engineering within a regulated environment (Pharmaceutical/Medical Device).
2. Experience in setting Thermal Inkjet and Thermal Transfer printers for cut roll stock labels and cartons.
3. 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 1G/Stamp 4 visa to apply!
Apply via this advert or contact Adam Murphy at LSC if you have any more questions about this opportunity!
Skills:
Packaging, Process Improvements, Manufacturing, Lean 6
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