LSC have a great contract opportunity for a Project Engineer to join a multinational medical device company based in Cork.
If you have 1 years of experience in R&D and/or Technology related roles and are ready for your next challenge, this could be the perfect role for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Team member representing the Engineering function supporting projects with a focus on capacity expansion, install, validation, of assets used in the manufacturing processes.
- Prepare several documents as part of the IQ, OQ, PQ processes.
- Responsible for ensuring design of machine is aligned with operations needs, quality, EHS, validation, quality automation, maintenance requirements.
- Validate the machine as per the specifications, procedures, regulations
- Determine operational & 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?
- BSc in Engineering or Science with 2 years' experience in a medium to high volume manufacturing environment
- 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
- 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.
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!
