Position Overview: We are seeking a highly motivated Validation Engineer onsite at one of our five sites: Cranberry Twp., Sturgeon Bay, WI, Suffield, CT, Staunton, VA or Cranston, RI sites, to lead and support validation activities across multiple projects at our facility.
This role is critical in ensuring compliance with regulatory standards (FDA, ISO 13485, 21 CFR Part 820), working closely with engineering, QA, and manufacturing teams.
Key Responsibilities:- Develop and execute validation protocols. (IQ, OQ, PQ, TMV)
- Maintain detailed validation documentation. (VMPs, reports, SOPs)
- Conduct risk assessments and manage change controls.
- Ensure regulatory compliance. (GMP, GLP, CSV, data integrity)
- Collaborate cross-functionally to support validation strategy and training.
- Monitor system performance and lead requalification activities.
- Qualify suppliers and vendors.
- Contribute to process improvements and continuous improvement initiatives.
Qualifications:- Bachelor's in Engineering, Life Sciences, or related field.
- 3+ years' experience in validation or quality in a regulated industry.
- Knowledge of FDA, ISO 13485, 21 CFR Part 820 standards.
- Proficiency in Microsoft Suite; experience with validation software.
- Strong communication, documentation, and analytical skills.
- Preferred: Lean/Six Sigma certification; experience with LMS systems.
Work Environment: Split between office and production floor. Requires clear communication, computer use, and occasional physical movement around facility.
We are not offering sponsorship at this time for this position.
