Validation Manager

JOB TITLE: 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 Master's 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 Bachelor's 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 <1058>, 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.

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