Validation Engineer
About The Position
The Validation Engineer supports validation and sustaining engineering activities for manufacturing equipment and systems in a regulated IVD environment, with emphasis on automation and controlled temperature systems. This role will work within the Global Operations Manufacturing team to support the site ma activities. Lead quality improvement efforts to reduce department nonconformances, and drive action through continuous improvement or CAPA. Collaborate cross-functionally with Manufacturing Operations, Process Engineering, MSAT, Quality Assurance, and Regulatory Affairs to support manufacturing design updates, labeling changes, and process improvements.
Requirements
- Bachelor’s degree in engineering or related technical discipline, or equivalent combination of education and relevant experience
- 2+ years of experience in manufacturing engineering, validation, or operations support within a regulated environment.
- Experience in medical devices, diagnostics, pharmaceutical, or IVD manufacturing environments
- Working knowledge of ISO 13485, FDA, and MDSAP requirements
- Working knowledge of equipment and software qualification and validation principles (IQ/OQ/PQ)
- Strong attention to detail and documentation discipline
Nice To Haves
- Hands-on experience with automation technologies in downstream fill and assembly operations (PLC-controlled systems, vision inspection systems, labeling equipment)
- Experience working with controlled temperature and refrigeration systems (e.g., refrigerators, freezers, incubators, cold rooms)
- Working knowledge using statistical tools (Minitab) for statistics-based approach to validation.
Responsibilities
- Execute validation activities across the equipment and software lifecycle, including IQ/OQ/PQ, to support new equipment introduction, changes, and maintenance of the validated state
- Author and execute validation protocols and reports in compliance with quality system requirements
- Provide direct support to production teams to ensure equipment readiness and sustained compliance, including execution of IQ/OQ activities
- Support qualification of automation systems (PLC-controlled equipment, vision systems, labeling platforms), software and controlled temperature/refrigeration units
- Support validation of facility and infrastructure changes, including utilities and environmental conditions
- Apply statistical sampling best practices and statistical methods to evaluate reliability and product quality
- Develop and execute Gage R&R studies for test methods and inspection systems
- Contribute to process risk analysis (e.g., FMEA) to identify and mitigate risks
- Support supplier evaluation and qualification of materials and components for lifecycle sustaining
Benefits
- bonus
- stock
- benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
