LSC have a great contract opportunity for a 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Responsible for strategy development, project management and regulatory compliance for process validation projects. Strategically leads and project manages complex process validation projects across a variety of disciplines.
- Responsible for management of internal process validation resources during project execution and provision of mentorship and SME support to more junior members of the process validation team and cross functional groups as applicable.
- Identifies and leads implementation of improvements to the GMSAT process validation systems.
- Executes Process Validation activities related to the various Process Validation disciplines
- Develops Process validation plans for specific system implementation projects.
- Establishes site process validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
- Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.
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 LSC on 021-4777329 if you have any more questions about this opportunity!