LSC have a great contract opportunity for a Project Engineer to join a multinational medical device company based in Cork.
If you have BSc in Engineering or Science with 2 years' experience in a medium to high volume manufacturing environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Prepare several documents as part of the IQ, OQ, PQ processes.
- Support colleagues to complete several tasks
- Responsible for ensuring design of machine is aligned with operation's needs, quality, EHS, validation, quality automation, maintenance requirements.
- Validate the machine as per the specifications, procedures, regulations
- Determine operation & process inputs and outputs ranges of machine prior to commencing validation
- Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ, OQ, PQ) s of assets and associated machines.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
- A thorough understanding of GMP/ISO and validation regulations.
- 1 year in a similar capacity in a regulated industry (i.e., FDA/ISO)
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 Conor Dolan at +353 21 4777 329 if you have any more questions about this opportunity!
