Validation Engineer
On-siteBray, Leinster, Ireland
Job Summary
Validation Engineer at Jabil Bray, Ireland: develops and implements validation and qualification policies, procedures and protocols; reviews and analyses protocol data to determine if requirements are met; prepares protocol reports for internal and customer review; champions the change control process for critical equipment and systems; coordinates and manages validation and qualification strategy for equipment and processes, including FAT, IQ, SAT, OQ, and PQ; ensures compliance with Quality Management System and regulatory standards; requires BS in Engineering and 1-3 years of experience in validation/qualification in healthcare or regulated environments; familiarity with ISO 13485:2016 and 21 CFR parts is a plus; may involve travel.
Required Qualifications
- BS in Engineering or Equivalent
- 1-3 years of experience in validation or qualification in healthcare or other regulated field
- Experience in software validation is preferred
- Hands-on experience with automation systems and tools used in equipment or process validation
- Working knowledge of ISO 13485:2016 or equivalent
- Knowledge of 21 CFR 820, or 21 CFR 210, 211 and Part 11, a plus
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