Senior Manager, Validation

Senior Manager, Validation
Boxborough, MA

Our client is one of the world’s leading suppliers to the virotherapy markets. For their newly established facility in Boxborough, Massachusetts, they are seeking a Senior Manager, Validation reporting to the Vice-President, Quality. This is a hands-on opportunity to build a Validation Master Plan from the ground up as a highly visible subject matter expert.

What You’ll Do:

  • Manage Site Validation Master Plan and deliverables
  • Serve as site subject matter expert in validation to support regulatory inspections and client audits
  • Develop validation lifecycle policies and procedures in alignment with regulatory standards and industry best practices
  • Support change controls for complex process, validation, analytical, equipment, facility/utility and/or automation changes
  • Author or manage authoring of qualification and validation plans, validation protocols, validation summary reports and requirement trace matrices.
  • Review and approve qualification and validation deviations and discrepancies, support investigations and corrective actions
  • Participate in design reviews and have experience in reading P&ID’s and various engineering drawings
  • Manage computer system validation
  • Review project documentation (URS, Technical Specifications, and Functional Specifications)

Who You Are:

  • Hands-on, self-motivated team player
  • Bachelor’s degree in Engineering, Science, or related technical field
  • Excellent technical writing and verbal communication skills
  • Experience in late-phase or commercial biotechnology GMP manufacturing operations including experience in cell culture or fermentation, purification, and lyophilization
  • In-depth knowledge of FDA regulations 21 CFR part 11, 210, 211, 600 and corresponding EU regulations
  • In-depth knowledge of ICH Q7 Q8, Q9, Q10 and other international regulatory requirements
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio