Validation Project Manager (Design Group)

BarryWehmiller   •  

Fairfield, CA

5 - 7 years

Posted 269 days ago

This job is no longer available.

Validation Project Manager will interface with our clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment. This role may also support the development and execution of validation scope such as FATs, SATs, CTPs, IQs, OQs, PQs, PVs and other validation life cycle documents.

              Experience

  • Minimum of 5years experience with increasing responsibility in project management of life sciences, biotech or other FDA regulated validation projects.  
  • Diverse experience in leading project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable. 
  • Project Managementexperience in managing scope, cost,schedule, quality andrisk isrequired.

    Requirements/Responsibilities

  • Validation Project Manager will interface with our clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
  • This role may also support the development and execution of validation scope such as FATs, SATs, CTPs, IQs, OQs, PQs, PVs and other validation life cycle documents. 
  • The Validation Project Manager will be responsible for developing project scope statements, estimates and proposals. 
  • This role may also assist in the development of policies, programs and project master planning.
  • This position requires experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously. 
  • Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired. 
  • Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
  • This position requires strong leadership, verbal communication, technical writing, project management tools and word processing skills.

             Education

  • BS Degree in Engineering or related technical degree. Project Management Professional (PMP) certification is desirable.

R001749