LSC have a great contract opportunity for a Validation 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:
- Proven experience with autoclaves, bioreactors, and HVAC systems requalification.
- Experience with cleaning validation (preferable, but not required).
- Strong knowledge of GMP, FDA, and EMA regulations.
- Develop and execute validation protocols (IQ, OQ, PQ) and validation reports to ensure compliance with regulatory and internal standards.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A BEng or BSc degree is preferred
- Minimum of 5 years of experience in validation engineering.
- Ability to work efficiently in a fast-paced, team-oriented environment.
- Proven ability to handle and prioritize multiple tasks.
- Excellent analytical, problem-solving, and organizational skills.
Note: 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 Sarah Ninan at LSC on 021-4777329 if you have any more questions about this opportunity!
