Cleaning Validation Specialist

Job Description

Job Description

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Cleaning Validation Specialist to work for a leading Greater Los Angeles area contract development and manufacturing organization.

Salary: $90-100k+/year depending on experience

Responsibilities:

• Develop, write, and review cleaning validation protocols, reports, and standard operating procedures (SOPs) in accordance with GMP regulations and global procedures.
• Establish acceptance criteria for cleaning validation based on product residues, cleaning agents, and microbial contaminants.
• Plan and execute cleaning validation studies, including surface sampling, rinse sampling, and swabbing of equipment and facilities.
• Conduct analytical testing associated to cleaning validation, to include Total Organic Carbon (TOC) testing
• Coordinate with production and quality control to schedule and perform validation activities.
• Analyze cleaning validation data to ensure compliance with established acceptance criteria.
• Prepare detailed validation reports summarizing findings, deviations, and corrective actions.
• Ensure all cleaning validation activities comply with relevant GMP guidelines, including FDA, EMA, and other regulatory bodies.
• Align local site-based procedures with global SOP’s.
• Stay current with regulatory updates and industry best practices related to cleaning validation.
• Identify opportunities for process improvements in cleaning procedures and validation practices.
• Participate in root cause analysis and implement corrective and preventive actions (CAPAs) for cleaning validation deviations.
• Provide training to production and quality staff on cleaning procedures and validation requirements.
• Maintain comprehensive and up-to-date documentation of all cleaning validation activities.
• Work collaboratively with production, quality assurance, quality control, and regulatory affairs to ensure cleaning validation requirements are met.
• Site representative for the global cleaning validation team to align on bets practices, globally
• Support internal and external audits related to cleaning validation processes.

Experience/Requirements:

• BA/BS in Chemistry, Microbiology, Engineering, or a related field; advanced degree preferred
• 3-5+ years of experience in cleaning validation within a GMP-regulated pharmaceutical manufacturing environment
• Strong understanding of GMP regulations, cleaning validation principles, and pharmaceutical manufacturing processes

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