Engineer I, Validation
- Research Triangle Park, NC
- Department: Engineering
- Region: US
The Validation Engineer I designs and develops validation protocols in addition to provides expertise to associated equipment and automation design / modifications.
Additional responsibilities include but are not limited to:
- Coordinates Equipment & Cleaning Validation Protocols (development & management) for specific equipment areas – including presentation of technical training & support to personnel, with on-floor guidance.
- Leads validation innovation project efforts requiring cross-functional & contract resources.
- Completes project management tracking of deliverables for metrics & reporting.
- Authors sections of Validation-related reports & project plans, provides technical evaluations of validation requirements for core change controls & associated action plans.
- Provides input & validation expertise to Technology Transfer & project / area support efforts.
- Bachelor's Degree in a relevant discipline (preferred) or an equivalent combination of education and experience
- One to two (1-2) years related experience.
- Industry Knowledge on GMPs and FDA audits
- Experience in Cleaning and Equipment Validation Philosophy
- Practical knowledge and application of GMP and EMEA regulations
- Experience in pharmaceutical or biotech manufacturing environment
The incumbent coordinates & supports validation related to the manufacturing equipment; provides on the floor execution support, tracking, and updates by performing duties personally or through subordinate supervisors.