Highlights
We are currently looking for a Cleaning Validation Specialist to work for a leading Greater Los Angeles area contract development and manufacturing organization. Work collaboratively with production, quality assurance, quality control, and regulatory affairs to ensure cleaning validation requirements are met.
Numbers & Facts
| Location | Los Angeles, CA |
| Industry | Accounting and Auditing Services |
| Salary | $90,000–$100,000 Per Year |
| Company Size | 20 to 49 employees |
| Year Founded | 1998 |
| Website | http://www.biophaseinc.com/ |
Description
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!!!
About Company
Our mission is to have a profound and positive impact on the performance of Biotechnology and Pharmaceutical companies in California by providing high quality scientific, clinical research and administrative personnel to such a noble industry. Whether you are a recent life science graduate or a seasoned clinical research associate looking for a managerial opening, BioPhase Solutions can locate the right opportunity to fit all your needs.
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