The Aseptic Processing Validation Manager role is a leadership position within the Aseptic Process Validation team. This team performs validation and requalification of equipment used in primary and secondary Drug Product Manufacturing, ensuring compliance with company procedures and industry standards.
Key Responsibilities:
* Provide leadership and guidance to the validation team, setting clear goals and expectations for daily activities.
* Support Operations in delivering and maintaining qualified equipment, ensuring validation approaches are based on scientific evidence and professional judgment.
* Develop and maintain internal policies, procedures, and practices associated with maintenance of the Site Validation Master Plan and Requalification Plans.
* Manage and coordinate the aseptic process simulation program, including review of protocols and summary reports.
* Collate and report on relevant validation data and metrics.
* Provide validation support for Amgen's quality management system, including change control, deviation, and CAPA processes.
Requirements:
* Masters degree with 5+ years of experience in validation, engineering, or microbiology, or BS degree with 7+ years of experience in these fields.
* In-depth understanding of validation principles, concepts, practices, and standards.
* Knowledge of cGxP regulations and compliance requirements for Biologics Drug Product manufacturing.
* Extensive working knowledge of sterilization/decontamination systems and industry practices.
* Experience with critical HVAC systems and qualification of AVS.
* Demonstrated ability to work in a fast-paced environment and adjust workload based on changing priorities.