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Validation Specialist

SciPro
Los Angeles, CA Temporary
POSTED ON 2/9/2025
AVAILABLE BEFORE 5/10/2025

Validation Specialist

Torrance, CA (5 days onsite)

Initial 6-month Contract

The Opportunity :

Enhance and Optimize Cleaning Validation Protocols

  • Develop, review, and refine cleaning validation protocols, reports, and SOPs to ensure compliance with GMP and global regulatory standards.
  • Establish acceptance criteria for residues, cleaning agents, and microbial contaminants.

Lead Cleaning Validation Activities

  • Plan and execute cleaning validation processes, including surface, rinse, and swab sampling.
  • Conduct analytical testing, such as Total Organic Carbon (TOC) analysis.
  • Collaborate with production and quality teams to ensure validation activities are completed efficiently and on schedule.
  • Assess validation results to confirm compliance, addressing deviations as needed.
  • Prepare comprehensive validation reports, documenting corrective actions where required.

    • Ensure Regulatory Compliance

  • Maintain adherence to industry regulations, including GMP standards and global regulatory requirements.
  • Align site-specific procedures with corporate validation guidelines and stay updated on industry advancements.
  • Identify and implement improvements in cleaning validation strategies.
  • Conduct root cause analysis and implement CAPAs to resolve deviations.

    • Collaborate and Train Across Teams

  • Train production and quality teams on cleaning validation protocols and industry best practices.
  • Maintain thorough and accurate documentation of all validation activities.
  • Work closely with cross-functional teams, including QA, QC, and regulatory affairs, to support validation initiatives.
  • Participate in global discussions on cleaning validation best practices.
  • Support internal and external audits related to cleaning validation.

    • Required Skills, Experience, and Education

  • Bachelor’s degree in Chemistry, Microbiology, Engineering, or a related field (Advanced degree preferred).
  • 3-5 years of experience in cleaning validation within a GMP-regulated manufacturing environment.
  • Strong knowledge of GMP regulations, cleaning validation principles, and pharmaceutical or biotech manufacturing processes.

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