Validation Supervisor (Canton, MA)
Advanced BioHealing Inc.
About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our mission is to advance healing and recovery beyond expectations. What You Will Achieve: The Validation Supervisor will be designated to support and supervise validation activities at Canton, MA facilities. In this role, the candidate will be responsible for developing strategies for validation of facility, equipment, utilities for manufacture of OI products. The candidate will develop protocols, and maintain records for installation, operation, performance qualification and requalification/revalidation protocols for manufacturing equipment, clean rooms and utility systems using GMP validation standards and procedures. In addition, the Supervisor will also assist in process and equipment validations. The position has interaction with all other internal departments. The supervisor will be responsible for overseeing the activities of Validation Engineers, including the scheduling, review, and approval of validation protocols and reports. This position reports to the Associate Director of Validation and is an on-site position at our Canton, MA facility Monday - Friday. How You Will Achieve It: Develops plans and coordinates activities for validation of GMP equipment including autoclaves, glass washers, depyrogenation ovens, utility systems (purified water, WFI water, gas systems, clean steam), incubators, clean rooms, freezers, smoke studies, and cold rooms for products. Oversees the activities of the Validation Engineers, including training, project scheduling and timely completion of established tasks. Maintains the requalification schedule for GMP equipment. Inputs new equipment into qualified database for tracking of GXP equipment. Captures required updates to the Validation Master Plan for the Site. Develops and implements standards and procedures to be used in the creation of validation protocols and reports. Reviews protocols and reports for validation and revalidation work as necessary Review of QC Laboratory equipment validations and other CSV type qualifications. Performs testing using standard concepts, practices and procedures of the cGMP process as required Assist as a technical resource for process and equipment validations as required. Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects Contribute as the validation representative on cross functional project teams. Orders necessary supplies for support of ongoing qualifications. Reviews and approves Quality Systems documents such as Change Controls, Deviations, CAPAs where applicable
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