Engineer I, Validation

  • Research Triangle Park, NC
  • Full-time
  • Department: Engineering
  • Region: US

Job Description

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.

Qualifications

  • 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

Additional Information

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.

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