Responsible for the development and execution of Validation activities including, design, installation, operational and performance qualification and Validation for manufacturing and packaging facilities/utilities/systems/equipment (FUSE) and cleaning activities. Working knowledge of Computer Systems Validation (CSV) and Continuous Process Validation (CPV) principles.
Essential Duties & Responsibilities
Assists in the change management for validated processes, FUSE, and CSV.
Assists in development and management of Validation Programs/Processes.
Generates and maintains site and project Validation Plans.
Updates, manages, leads, and executes FUSE, process, and CSV re-qualification schedules/activities.
Manages, schedules, and coordinates Validation activities with cross-functional teams.
Assists cross-functional teams in FUSE, process, and CSV procurement and requirements.
Manages, leads, generates protocols/reports and executes Validation activities for the following FUSE and CSV; GMP Manufacturing FacilitiesTemperature controlled environments (Warehouse, Stability Chambers, Incubators, Freezers, Water baths, Refrigerators, Hot boxes, etc.)Injectable aseptic manufacturing equipment (Fillers, Wetmill, Bulk Tanks, etc.)Dermatological manufacturing equipment (Mixers, Tanks, Fillers, Homogenizers, etc.)Utilities (WFI, Purified (USP), DI, Clean Steam, etc.)Laboratory equipment (HPLC, TOC, Laminar Flow Hoods, BSC, etc.)Sterilization equipment (Autoclaves, Dry Heat Ovens, Steam in Place (SIP), Isolators, etc.)Cleaning equipment (Clean in Place (CIP), Parts Washer)Laboratory Information Management Systems (LIMS)Electronic Document Management Systems (EDMS)
Manages and provides guidance and technical expertise in cycle development initiatives and activities.
Manages and provides guidance and technical expertise in cleaning and process development/commercial activities.
Collaborates with Management personnel as needed.
Participate in audits and follow up on corrective actions.
Contribute to the development of departmental budget and monitoring of expenditures.
Train, mentor, and supervise junior associates in validation principles.
Perform other related duties as assigned.
Education & Experience
Bachelor s degree in Engineering or Science related field. Post Graduate work a plus.
Ten or more years experience in the pharmaceutical industry, minimum eight years in validation required.
Some experience in Statistical Analysis preferred.
In depth knowledge of current validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.