Sr. Validation Manager

Job Summary The Validation Manager has responsibility for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System. The Validation Manager isresponsible for ensuring the equipment, manufacturing and testingfacilities and utilities serving thefacilities are validated and any revalidation studies are performed. The Validation Manager has responsibility for authoring and maintaining the Validation Master Plan for the Production and Quality Control areas of the site andsupport areas. As part of theseresponsibilities, the Validation Manager may author and execute validation protocols and validationreports or will review and approve the protocols andreports that are prepared by the validation team. In addition, the Validation Manager may be expected tosupport global manufacturing anddistributionsites within VWR as part of the Global Compliance Team. MAJOR JOB DUTIES AND RESPONSIBILITIES  (List in order of importance) Responsibility for designing, maintaining and continually improving the validation system in line with current national and international standards. Responsible for implementation and ongoing improvement of validation policies and procedures within the Avantor Quality Management System.  Provide technical expertise and guidance on validation policies and procedures and the implementation of those within the Operations and Quality Control (QC) functional areas. Designs, authors and aids in the execution of validation protocols. Responsible for developing and executing matrix type validations where applicable for processes and equipment with adequate supporting rationales. Responsible for oversight and execution of validations for production, manufacturing and cleaning processes.  Authors process validation protocols and reports. Responsibility for ensuring validation studies of the operations and quality control facilities, the utilities serving the facilities and manufacturing/operations areas, and testing equipment are completed to the required cGMP standards. Summarizes studies and authors validation reports in compliance with the Avantor Quality System and cGMP standards. Prepare and maintain Validation Master Plans for the facility, utility, and equipment to ensure they are all adequately validated for cGMP projects undertaken within the facility.  Manage team members. Maintain the Revalidation Plan for the manufacturing and quality control facilities, the utilities serving the facilities and all manufacturing and testing equipment and ensures all revalidation is performed and reported. Work with Design Engineering on Impact Assessments, GAMP and DQ assessments for all equipment with appropriate input from the Users and Quality Assurance. Make   proposals   and   implement   actions   as   part   of   the   continuous improvement program to improve validation policies and procedures. Supervise Production Operators and QC analysts during validation studies as required. Present the validation policies and procedures and validation studies to Regulatory and Customer auditors as required. Responsible for development and maintenance of department/validation metrics. Designs, authors and executes validation protocols in compliance with the Avantor Quality System and cGMP standards. Performs other duties as assigned QUALIFICATIONS (Education/Training, Experience and Certifications) B.A. or B.S. degree (preferably in Life Science) 8+ years applicable experience preferably in a pharmaceutical, biopharmaceutical or IVD industry 3+ years leadership experience Project management experience KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently) Knowledge of cGMPs or equivalent regulations Ability to interpret and relate Quality standards for implementation and review Ability to make sound decisions about scheduling, allocation of resources, and managing priorities Strong written and oral communication skills Strong computer skills required: working knowledge of Minitab; functional knowledge of Microsoft Outlook, Word, and Excel. Demonstrated knowledge and experience with software systems and integration with the quality system. Ability to analyze, investigate and propose approaches to technical and regulatory issues. Ability to design, execute and analyze manufacturing process validation studies. Ability to manage multiple concurrent tasks/studies. Ability to execute the Validation Plans for medical device and related product manufacturing equipment and facilities. R-105801
Salary Range: NA
Minimum Qualification
8 - 10 years

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Sr. Validation Manager
Devens, MA Avantor, Inc.
Sr. Product Manager, Networking Solutions
Andover, MA Philips
Sr Data Management Vendor Manager - Analytics ...
Cambridge, MA Biogen Idec
Sr Property Manager
Boston, MA Newmark Knight Frank
Pre-silicon Validation Manager
Hudson, MA Intel Corp.
Sr Product Manager, Logo Products
Groton, MA Deluxe Corporation