Project Engineer
Berkley Group
- Southside Dublin
- Contract
- Full-time
- Team member representing the Engineering function supporting projects with a focus on capacity expansion, installation, 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 operation's needs, quality, EHS, validation, quality automation, maintenance requirements.
- 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) of assets and associated machines.
- Partner with Quality, Operations, CSV, and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
- Provide timely and accurate reporting and management of escalations as appropriate on project activities.
- Ensure all activities comply with GMP, ISO and quality system requirements.
- 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.
- A thorough understanding of GMP/ISO and validation regulations.
- Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Understanding of the Mechanical Engineering process and Process Validation expertise is preferred.