Validation Engineer
An exciting opportunity for an experienced Validation Engineer to work with an Irish award-winning leader in the automation industry. Based in Shannon, Co. Clare, this industry leader has been providing high-tech, high-value, equipment to the worlds largest and most reputable medical device and ICT companies.
The Validation Engineer will manage the creation, revision and delivery of GAMP documentation to FDA regulated companies in accordance with approved SOP’s, GMP’s, and all other regulatory requirements.
Responsibilities will include:
- Generating validation documentation including risk assessments, traceability matrix, and validation plan/reports.
- Development and review of software validation test protocols including FAT & SAT protocols.
- Participate in FAT and SAT protocol execution as necessary.
- Collate and organise all qualification files for the project (including Test protocols, Reports, etc.)
- Document, investigate, and report all deviations / exceptions during the qualification activities.
- Coordinate qualification activities with contractors and vendors as required.
- Travel may be required.
The ideal candidate will have:
- A Primary Degree BSc / BEng
- 3+ years’ experience in a validation role within the Medical Device or Pharmaceutical Industry.
- Knowledge of Computer System Validation including GAMP5, 21 CFR Part 11, and cGMP requirements.
- Proven track record in developing validation documents for the pharmaceutical and medical device industry.
- Excellent technical skills including proficiency in Word, Excel, PowerPoint & MS Project.
The ideal candidate will receive:
- A very competitive salary and benefits package including Healthcare & Pension.
- The opportunity to become part of a highly skilled team working in a state-of-the-art building.
To apply, please forward a copy of your CV, in Word format, to angelina.oneill@eflexes.com or telephone 086 0205506 to discuss in confidence.
