Validation Engineer - Holt Area
$75,000–$114,000 year
On-siteHolt, Michigan, United States
Job Summary
Develop and execute validation protocols for equipment, processes, and software while performing IQ, OQ, and PQ activities for new and modified systems. Analyze validation data to author comprehensive reports and investigate deviations or non-conformances during activities. Ensure all work complies with cGMP, FDA, and internal quality standards while maintaining documentation throughout the system lifecycle. Collaborate with cross-functional teams including R&D, Quality, and Manufacturing. This role supports regulated manufacturing environments in Holt, MI, with a focus on medical device, pharmaceutical, or biotech sectors.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical field
- 2+ years experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech)
- Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485)
- Experience with various validation methodologies including IQ, OQ, PQ, process validation, and software validation
- Proficiency in writing and executing validation protocols and reports
Desired Qualifications
- Experience with statistical process control (SPC) and data analysis tools (e.g., MiniTab, JMP)
- Familiarity with automation systems and software validation (e.g., SCADA, DCS, PLCs)
- Certified Quality Engineer (CQE) or similar professional certification
- Knowledge of cybersecurity principles as they apply to manufacturing systems
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