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Cleaning Validation Specialist
Cleaning Validation SpecialistBioPhase Solutions • Los Angeles, CA, US
Cleaning Validation Specialist

Cleaning Validation Specialist

BioPhase Solutions • Los Angeles, CA, US
[job_card.30_days_ago]
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  • [job_card.full_time]
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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
Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
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Cleaning Validation Specialist • Los Angeles, CA, US

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