Summary :
This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV experience, represent CQV work in the regulator and internal audits, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.
Roles & Responsibilities :
• Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant
• Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks
• Supports and/or owns technical and quality investigations, CAPAs and corrections
• Develops and performs any required remediation efforts and associated CAPA plans
• Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, other applicable acceptance criteria, specifically data integrity
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews
• Train and support the junior team members on different CQV activities
• Support presenting CQV work to regulatory and internal audit teams
• Other responsibilities as assigned
Education & Experience :
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
A minimum of 8+ years relevant work experience is required.
