About this role

Prepare and review plans, protocols, reports, and studies associated with validation activities
Ensure that validation events occur in conformance with approved procedures and regulatory requirements
Coordinate the timing of validation events
Assess deviations and recommend corrective actions as necessary
Perform validation periodic reviews and revise/review master plans and standard operating procedures
Review technical documents to ensure that validation acceptance criteria are consistent with product and process specifications

Bachelor's degree in Engineering, Chemistry, Pharmacy or a closely allied field
One year of pharmaceutical industry experience required
High level of analytical skills with proven problem-solving ability
Experience in the interpretation and application of FDA requirements and cGMP
Ability to write technical documents relating to applications and systems of medium complexity
Demonstrated ability to organize multiple tasks and changing priorities to meet project deadlines
Excellent oral and written communication skills
Basic understanding of statistics preferred
Computer literacy is required.

Validation Engineer I

Key skills