The Validation Engineer will be responsible for the calibration and validation of equipment, processes, and systems at the Kankakee facility. The Validation Engineer will assist in equipment selection, specification, and negotiation of competitive pricing. The Validation Engineer also maintains all documentation pertaining to qualification and validation and will be responsible for developing procedures and/or protocols. The Validation Engineer will serve as information resource for validation contractors and vendors, and as the Subject Matter Expert for customer audits and customer complaint responses.
Key Position Responsibilities:
- Develop and execute VMP, IQ/OQ/PQ protocols and reports
- Analysis data to support report conclusion
- Resolve qualification deviation
- Work to develop team consensus on validation strategies
- B.S. in related field
- 2+ years experience in manufacturing environment
- Experience in cGMP and cGAMP environments preferred
- Experience in validation processes
- Ability to work in a dynamic team environment
- Excellent verbal and written communication skills required
- Strong ability to influence others.
- Excellent inter-personal skills
- Ability to manage multiple priorities at one time
- Statistical analysis skills (i.e. Gage R&R, DOE, Regression)
- Computer literacy required
EMD Serono - 22 months ago
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