Job Description

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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