LSC has a great contract opportunity for Technical Operations Specialist to join a leading biotech company based in Cork.
ABOUT THE PROJECT - KEY RESPONSIBILITIES
- Conduct Technical Operations activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.
- Develop Technical Operations documentation as required (e.g., strategies, plans, protocols, procedures, reports).
- Review and approve documents prepared by other Technical Operations colleagues.
- Execute Technical Operations protocols as required.
- Liaise with Manufacturing to provide support where required with routine operations / project-based work
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Experience in biological Process Validation or biological manufacturing.
- Experience in Projects, New product introduction (e.g. Supporting: Process Improvement Projects / Process Validation campaigns)
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities.
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 Peter Cronin at 021 4777329 if you have any more questions about this opportunity!