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Senior Validation and Operational Excellence Specialist

2 months ago

Arcadia, California, United States Theragent Inc Full time
Job Summary

Theragent Inc. is seeking a highly motivated and experienced Validation and Operational Excellence Engineer III to lead and support validation, business analysis, and operational excellence projects to bring up a CGMP facility for cell and gene therapy.

Key Responsibilities
  • Validation and Operational Excellence
    • Lead and support GMP validation projects of moderate to high complexity, including equipment, instruments, computerized systems, utilities, facilities, processes, and temperature mapping.
    • Develop and implement qualification and validation lifecycle documents, execute associated studies, analyze data, and develop final reports.
    • Serve as Theragent Validation SME for validation project scopes, approaches, and rationales.
    • Develop Standard Operating Procedures to mature the Theragent Validation program.
    • Support validation deviation investigations and determine assignable cause.
    • Review validation lifecycle documentation, including requirements, specifications, protocols, and reports.
    • Act as validation signatory representative to approve validation documentation, accountable to Theragent management and regulatory agencies.
  • Business Analysis and Operational Excellence
    • Champion the implementation of new technologies and systems to meet business needs.
    • Conduct interviews and workshops to gather business and workflow requirements, creating detailed specifications and process documentation.
    • Collaborate with IT and other departments to design viable solutions, develop test plans, and organize user acceptance testing (UAT).
    • Drive and improve results by leveraging lean tools, consulting skills, and change management processes.
    • Define KPIs, metrics, and continuous improvement goals within the organization to drive business objectives.
Requirements
  • A minimum of 4-6+ years of relevant Validation, Business Analysis, and/or Operational Excellence experience in a CGMP environment.
  • A Bachelor's degree in a science-related field, preferably Life Sciences or Engineering. Advanced degree is a plus.
  • Strong background in computer system validation (CSV) is required.
  • Six Sigma certification is a plus.
Working Conditions
  • Primarily office environment but will be required to enter GMP laboratory or manufacturing areas.
  • Must be able to read, write, and converse in English.
  • Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25lbs.
  • Ability to sit, stand, walk, and move within workspace for extended periods.
  • Ability to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling.