La Jolla, CA
Job ID: 622
Job Req code: 622
Category: Quality Systems
Job Type: Quality Assurance
Job Summary: The Validation Manager will support manufacturing, facilities and engineering operations by managing validation activities at our La Jolla, CA facility. In this role, the Manager is responsible for developing test / qualification protocols, and maintaining records for installation, operation, performance qualification and requalification/revalidation protocols for manufacturing equipment, clean rooms and utility systems, by using established validation standards and procedures.
In addition, the Manager will draft and participate in executing protocols for process validations and cleaning validations. The position has interaction with all other internal departments. The Manager will be responsible for overseeing the activities of Validation Engineer(s), including the scheduling, review, and approval of validation protocols and reports.
- Coordinates and executes validation studies for GMP equipment including autoclaves, washers, depyrogenation ovens, packaging equipment, clean utility systems (purified water, WFI, house vacuum, clean compressed air), incubators, freezers, clean rooms, cold rooms, and other equipment/systems as assigned.
- Oversees the activities of the Validation Engineer(s), including training, project scheduling and timely completion of established tasks.
- Maintains periodic qualification assessments and requalification schedules for GMP equipment.
- Maintains the Site Validation Master Plan.
- Drafts, reviews and approves protocols and reports for validation and revalidation work as necessary
- Drafts, reviews and approves semi-annual Aseptic Process Verification (APV) protocols and reports.
- Drafts, reviews and approves protocols and reports for process validation and cleaning validation as required.
- Maintains the quarterly dose audit systems for products, to verify gamma or e-beam irradiation sterilization of components per use of SIP tubing sets, manifolds and cassettes.
- Develops and implements standards and procedures to be used in the creation of validation protocols and reports.
- Participates in creation and/or review of Standard Operating Procedures (SOPs).
- Contributes as the Validation representative on cross functional project teams.
- Supports periodic regulatory FDA and ISO site inspections.
The candidate must have previous validation experience in Pharmaceutical/Biotech/Medical Device industries, be familiar with aseptic processing and clean room operations, be able to work independently, possess strong organizational skills, and have good written and verbal communication skills. Minimum Bachelor’s degree with 5+ years of experience validating cGMP systems. Previous supervisory / management experience in a GMP environment is required. Candidate will be a highly motivated and creative individual with strong hands-on validation skills. A high level of competency is preferred with Kaye and Agilent Validator programming, qualification of test equipment, validation of clean rooms and technical writing skills.
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