Validation Specialist

Validation SpecialistTorrance, CA (5 days onsite)Initial 6-month Contract The *****Enhance and Optimize Cleaning Validation ProtocolsDevelop, 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 ActivitiesPlan 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 ComplianceMaintain 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 TeamsTrain 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 EducationBachelor'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.

Created: 2025-02-20