Job Description
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 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 <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 . Reference 12140.627. EOE.
#LI-DNI
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 persons 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.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at
Required Experience:
Manager
Vertex Pharmaceuticals invests in scientific innovation to create transformative medicines for people with serious diseases.