Description
Minimum Requirements/Qualifications:- Bachelor's degree in Engineering or Science Field.
- Five years relevant experience in medical device or pharmaceutical arena.
- Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation, and computer/automation systems.
- Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
- Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
Other Responsibilities:
- Perform and lead Risk Assessment exercises in support of validation activities, and perform periodic reviews as needed.
- Collaborate with R&D to ensure successful process development and technical transfer to Operations.
- Coordinate validation activities in support of assigned validation projects working closely with Quality Engineering, Engineering team members, Operations Excellence, Operations, etc.
- Recommend approval or failure of validation reports.
- Maintain knowledge and comprehensive understanding of relevant Medical Device / pharmaceutical regulations and current interpretations affecting equipment, product, process and cleaning validation.
- Performs root cause analysis and suggest workarounds and/or solutions for recurring issues.