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Validation Manager

Validation Manager

VertexBoston, MA, US
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Validation Manager

Location : 50 Northern Ave, Boston, MA, 02210

Openings : 1

Duties :

  • Provides direction and technical leadership to validation contractor(s) to achieve effective and efficient resources utilization.
  • Employs a "hands-on approach" to leading the team, managing people, systems, and equipment validation activities.
  • Ensures that validation work follows all safety standards, conforms to end-user requirements / specifications, cGMP compliance, and that validation activities are tracked and completed within guidelines and schedule.
  • Expected to execute tasks and responsibilities with minimal guidance demonstrating outstanding multi-tasking, problem solving, and excellent communication skills, in a dynamic and challenging internal manufacturing environment.
  • Ensures a robust system is in place for the facility, equipment & laboratory, instruments including utilities, engineering, maintenance, and validation activities.

Requirements :

Employer will accept a Masters degree in Science or Engineering related field and 3 years of experience in the job offered or in a Validation Manager-related occupation. Alternatively, employer will accept a Bachelors degree in Science or Engineering related field and 5 years of experience in the job offered or in a Validation Manager-related occupation. Position requires demonstrable experience in the following :

  • Strong knowledge of validation and system implementations in a GMP manufacturing environment.
  • Able to perform complex assessments for automated processing systems against current industry compliance requirements.
  • Working knowledge of current CQV methods, including ISPE, ICH, and ASTM E2500 methodology.
  • Strong understanding of 21 CFR Part 11, USP
  • , cGMP, and other regulatory guidance for manufacturing equipment, analytical instruments, and automated processing systems.

  • Displays high competence in the utilization of core quality systems such as change control, deviations, investigations, CAPA management, and document control.
  • Rate of Pay : $162198.00 - $175500.00

    Contact : Send Resume to Ken Strecker at Ken_Strecker@vrtx.com. Reference 12140.627. EOE.

    Company Information :

    Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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    Manager Validation • Boston, MA, US

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