LSC have a great contract opportunity for a QA 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 +5 years’ experience in a cGMP regulated manufacturing environment, and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provide project management oversight for FUE activities related to the company’s products and facilities, utilities, equipment (FUE).
o Developing validation plans for specific system implementation projects.
o Performing and reviewing (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
o Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o +5 years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
o Organizational and management skills to coordinate multi-discipline project groups
o Ability to speak, present data, and defend approaches in front of audiences and inspectors.
o Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
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!
To apply submit your CV via this advert or contact Ruth Holland at LSC on 021-4777329 if you have any questions about this QA Validation Engineer opportunity!