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Astrix Technology Senior Validation Manager in Ocean County, New Jersey

Senior Validation Manager

Engineering

Ocean County, NJ, US

  • Added - 15/02/2024

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Position Overview:

  • Responsible for managing validation activities - equipment qualification, process validation, and cleaning and sterilization validation.

  • Responsible for generating, reviewing, and approving protocols, deviations, and reports, as well as scheduling manpower activities, providing customer feedback, ensuring on-time delivery of milestones, project staffing, and overseeing direct reports.

  • The individual will be a Subject Matter Expert (SME) overseeing validation activities for pharmaceutical manufacturing.

  • Provide team leadership, hiring, training, and managing employees, and defining project scope.

  • Provide leadership on validation and compliance requirements, and leading large-scale projects.

  • Develop and maintain validation best practices, stay current with regulations and industry practices, and provide technical expertise

Qualifications:

  • Master of Science OR Bachelor's degree in life science or engineering

  • Minimum 2 years of relevant experience managing validation activities in an aseptic pharmaceutical environment.

  • Prior management experience preferred

  • Familiarity with FDA, ISO, EU, and ICH guidelines and industry practices.

Salary: $150-175k/yr

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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