Validation Manager

Company: Michael Page
Location: Cumberland
Posted on: March 17, 2023

Job Description:

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 Engineer is responsible for ensuring the equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any re-validation studies are performed.Client DetailsThis client is a growing privately held biotech company.DescriptionThe Validation Manager has responsibility for authoring and maintaining the Validation Master Plan for the Production and Quality Control areas of the site and support areas. As part of these responsibilities, the Validation Manager may author and execute validation protocols and validation reports or will review and approve the protocols and reports that are prepared by the validation team.

• Responsible for crafting, 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 company Quality Management System, along with providing technical expertise within those functional areas.
• Responsible for developing and implementing 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.
• Designs, authors, and aids in the execution of validation protocols.
• Authors process validation protocols and report, along with developing and maintaining validation metrics.
• Responsible 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.Profile
  • B.S., or M.S. preferably in Chemical or Process Engineering or Biological or Pharmaceutical Science or other related science degree.
  • 3+ years applicable experience preferably in a pharmaceutical, biopharmaceutical or IVD industry
  • Knowledge of cGMPs or equivalent regulations
  • Ability to make sound decisions about scheduling, allocation of resources, and balancing priorities
  • Strong digital literacy required: shown understanding of Minitab; functional knowledge of Microsoft Outlook, Word, and Excel.
  • Proven knowledge and experience with software systems and integration with the quality system.Job Offer
    • Competitive base salary
    • Strong commission structure with significant upside
    • Excellent benefits package
    • Pivotal role for company's aggressive expansionMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Keywords: Michael Page, Providence , Validation Manager, Executive , Cumberland, Rhode Island