LSC have a great contract opportunity for 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:
- Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising supervised judgment within broadly defined procedures and practices to establish acceptance criteria.
- 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?
- 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.
- Organizational and management skills to participate in multi-discipline project groups
- Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate.
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 Sarah Ninan at LSC on 021-4777329 if you have any more questions about this opportunity!