Title: Validations Specialist-Commissioning and Qualification
Responsibilities:
- Reports on progress and roadblocks to the project team.
- Develop relevant protocols, execute protocols, and own C&Q activities for the decommissioning project for the commercial QC lab in San Diego
- Authors and/or manages authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and end of life periodic reviews
- Liaise with client end user groups to ensure project is successfully completed per industry and the Client guidelines.
- Validation using risk-based approach (FMEA, PHA, etc.)
- Authors and reviews project documentation, as needed. (URS, FRS, Technical Specifications, Functional Specifications)
- Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information
- Partners with Quality to ensure a quality and compliant environment
- Other related duties as assigned.
Top Three Skills:
- QC laboratory or manufacturing instrument background (especially commissioning and qualification)
- Calibration management – specifically engineers with calibration experience so they can help us close out WOs
- Experience in GMP environment, Pharma/Med-Device is a must (Pharma preferred)