Validation Supervisor

Position Summary Supervising a staff comprised of 2 to 5 Validation Engineers (Levels I and II) and Technicians to support not only current validation/revalidation programs but also production, Scientific Affairs, and contract manufacturing operations with validated processes/equipment.

Essential Duties

1. Supervise and coordinate activities of 2-5 Validation personnel. Provide technical support and guidance to other validation personnel or project team in protocol/report preparation, execution and data interpretation.
2. Reviews validation protocols and uses data analysis skills in assuring accurate interpretation of data.
3. Track projects to ensure completion within defined time lines
4. Writing, reviewing, or revising SOPs as related to validation policies or revalidation activities, as needed
5. Independently prepare written validation protocols including designing appropriate test experiments
6. Assists the validation manager in providing technical assistance and handling any questions or concerns from contract customers or agencies in reference to validation activities
7. Follows Safety, Health, and Environmental policies and procedures.
8. Other duties, as assigned, or as business needs require.

Position Requirements
Education Required: Bachelor?s degree in Biological/Life Sciences or Engineering and 4-6 years experience in pharmaceutical manufacturing or related field. Minimum of 3 years experience in validation. Minimum of 4 years experience in validation and at least two years supervisory experience/project management. In-depth knowledge of validation functions to support manufacturing, cGMPs, CFRs, pharmaceutical equipment and processes required.

Demonstrated proficiency in a minimum of 3 of the following specific areas of validation:
1. Terminal sterilization/depyrogenation
2. Aseptic processes (filling, compounding)
3. Pharmaceutical equipment/systems
4. Facilities/utilities
5. Computer systems (including PLC)
6. Packaging/inspection equipment
7. Process validation (fill volume, headspace, etc.)
8. Cleaning validation
9. Knowledge of use of instrumentation to conduct validation testing (e.g. Kaye Validator) required.