Validation Engineer - Spring Lake Area
$79,000–$119,000 year
On-siteSpring Lake, Michigan, United States
Job Summary
Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software. Perform risk assessments, generate validation plans, and analyze data to author reports summarizing results and conclusions. Investigate deviations and non-conformances during validation activities, implementing corrective actions while collaborating with cross-functional teams to ensure successful validation. Maintain all validation documentation in accordance with regulatory requirements and internal procedures. Support regulatory audits and inspections by providing validation documentation and expertise.
Required Qualifications
- Bachelor's degree in engineering or a related scientific discipline
- 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical)
- Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485)
- Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software
- Excellent technical writing skills for authoring validation documentation
Desired Qualifications
- Familiarity with Six Sigma or Lean Manufacturing principles
- Experience with statistical analysis software (e.g., Minitab, JMP)
- Knowledge of cybersecurity best practices for industrial control systems
- Demonstrated ability to mentor junior engineers or lead small project teams
- Professional certification (e.g., ASQ CQE, CSSBB, PMP)
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