The Senior Validation Engineer will be responsible to coordinate and execute the Process Validations, IQ, OQ, PQ qualifications.
- Perform IQ/OQ/PQ on manufacturing equipment used in the assembly of electro-mechanical medical devices (Intra-Aortic Balloon pumps).
- Inspect production processes and prepare protocols and summary reports for manufacturing, accessory and packaging equipment.
- Prepare, maintain, or review validation and compliance documentation, such as change notices, schematics, or protocols for sustaining operations
- Be the SME for validation for manufacturing transfers.
- Perform equipment validation, recommend and work with quality assurance to implement procedures to resolve production issues.
- Provide assistance to operations personnel in the development of procedures as needed.
- Write and/or review summary reports for the various equipment qualification studies performed.
- Address problems related to production, equipment, safety and quality.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Work with other departments regarding deviations, out of tolerance conditions and equipment issues observed during validation by conducting failure analysis, determining the root cause and taking corrective actions.
- Bachelor’s degree in S.T.E.M. (Science, Technology, Engineering, Math)
- 6 - 10 years’ experience in the medical device industry.
- Strong interpersonal and communication skills
- Excellent quantitative and analytical skills (including use of statistical software).
- Ability to prioritize tasks in a fast-paced environment.
- Must be able to use Microsoft Office products - Outlook, Word, Excel and PowerPoint.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
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