LSC have a great contract opportunity for a Global Process 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.
If you have 10 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Perform process validation activities related to drug substance and drug products, through defined clinical and commercial stages.
- Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes
- Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
- Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
- Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- 8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- 2+ years experience in a position utilizing formal project management a plus.
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 Cian Marnane at LSC on 021 4777329 if you have any more questions about this role!
