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Validation Specialist III


Location: Swiftwater, Pennsylvania
Job Category:

  • Responsible for delivering Single Use qualification (i.e. extractables and leachables) and quality management activities for new Flu start-up facility under the direction of a technical lead. Such activities may include (but are not limited to):
  • Author qualification protocols, reports, and risk assessments per single use qualification procedures and guidelines
  • Coordinate qualification activities with external testing partners and single use suppliers
  • Compile data and results into interim reports and presentations
  • Request and verifying various documentation from suppliers for qualification requirements
  • Assemble documentation packages to support quality management activities
  • Coordinate testing logistics including shipment of testing materials to and from external laboratories or partners, and ordering required materials
  • Assist team in performing SUS functional testing, procedure development, and troubleshooting
  • Manage inventory of SUS parts
  • Perform all work in accordance with project timeline and requirements
  • Work with procurement and MTech single use workstream lead to manage SU design finalization and bid acceptance with various stakeholders as well as managing design changes up until start of quality management of SU assemblies.
Skills:

Basic Qualifications:

  • BS in Science (e.g. Engineering, Biochemistry, Biology, Chemistry) with a minimum of 5 years of experience with qualification activities in bio/pharmaceutical production processes
  • Experience writing and revising documents (e.g. testing methods, protocols, reports)
  • Experience working cross-functionally in a project organization

Preferred Skills/Experience:

  • Experience in development and or validation related activities
  • Prior experience of Single-Use System technologies and qualification
  • Experience coordinating with Laboratory partners for testing
  • Proficiency in utilizing documentation systems to author protocols and reports
  • Strong organizational, prioritization, and task management skills
Education:

BS in Science (e.g. Engineering, Biochemistry, Biology, Chemistry) with a minimum of 5 years of experience with qualification activities in bio/pharmaceutical production processes


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