Validation Engineer II
Cadence, Inc. · Suffield, CT · 1 mo ago
Quality AssuranceFull-time
Key Responsibilities
- Develop and execute validation protocols. (IQ, OQ, PQ, TMV)
- Maintain detailed validation documentation. (VMPs, reports, SOPs)
- Carry out 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.
- Possession of Lean/Six Sigma certification; experience with LMS systems preferred.