Validation Specialist
Job Description
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Position Summary:
Responsible for all aspects of the validation process, including: documenting commissioning activities; establishing the process and equipment acceptance criteria; and developing and performing qualification studies to document evidence which provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attributes. Work closely with all departments and be responsible for various projects.
Essential Duties & Responsibilities:
Schedule and plan equipment and process qualification workload to meet approved schedules.
Handle multiple projects and work independently.
Write, execute, and review complex protocols.
Coordinate validation activities with other departments.
Operate Thermal Mapping Equipment
Able to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
Train other Validation personnel.
Purchase supplies and equipment for validation activities.
Administer the site Change Control Program.
Education and Experience:
Bachelor’s Degree from a four-year accredited college or university with Major Chemistry, Engineering, Microbiology, or a related field.
Minimum 4 years experience in the pharmaceutical industry, or equivalent experience.
Demonstrate experience validating a wide range of equipment and processes (including cleaning processes), including mixing, sterile fill, freeze drying, parts washers, vial washers, dehydrogenation, wet steam and dry heat sterilization, and packaging.
Demonstrate experience and knowledge of qualifying changes to validated systems/processes/and equipment.
Validation Specialist