What are the responsibilities and job description for the Cleaning Validation Specialist position at BioPhase Solutions?
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 :
Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
Salary : $90,000 - $100,000
