Aseptic Manufacturing Validator
1 day ago
Aseptic Manufacturing Validator Position
We are seeking an experienced Aseptic Manufacturing Validator to join our team.
The role involves providing technical expertise in validation activities, ensuring compliance with regulatory requirements.
Main Responsibilities
The Aseptic Manufacturing Validator will be responsible for validation oversight of External Manufacturing sites, including process, cleaning, filter, and sterilization/sanitization validation activities.
The candidate will also be responsible for validation document author/approver, ensuring validated parameters are correctly incorporated in Master Batch Records.
Regulatory aspects, such as Aseptic processing system oversight, will also be part of the role.
Other main responsibilities include validation change control assessment, performing Person in Plant activities, and authoring applicable MA filing sections.
The ideal candidate will have significant validation experience at Aseptic Manufacturing or API facilities, with at least 5 years (ideally 8 years +) of biotech or pharmaceutical industry experience.
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