Cleaning Validation Specialist

Responsibilities
Cleaning Validation Protocols and Reports:
Develop and review cleaning validation protocols, procedures, and final reports.
Ensure cleaning procedures meet all regulatory requirements (FDA, EMA, etc.) and company standards.
Execution of Cleaning Validation:
Coordinate and lead the execution of cleaning validation activities, including sampling, testing, and documentation.
Ensure cleaning validation is performed according to predefined protocols.
Conduct visual inspections and swab sampling to ensure thorough cleaning of equipment and manufacturing areas.
Data Analysis and Review:
Analyze and interpret data from cleaning validation studies to ensure processes consistently remove product residues.
Troubleshoot cleaning failures and investigate root causes in collaboration with the Quality and Production teams.
Documentation and Record Keeping:
Maintain accurate and detailed records of all cleaning validation activities.
Ensure validation reports are timely and meet the standards for internal and external audits.
Qualifications
Education:
Bachelor's degree in Chemistry, Microbiology, Engineering, or a related scientific field
Experience:
3- years of experience in cleaning validation within a pharmaceutical or biotechnology manufacturing environment.
Knowledge of cGMP, FDA, and EMA regulations related to cleaning validation.
Skills:
Strong analytical and problem-solving skills
Excellent communication and technical writing abilities
Attention to detail and commitment to maintaining high-quality standards
Ability to work independently and as part of a team
Job Types: Full-time, Contract
Pay: $33.00 - $40.00 per hour
Schedule:
8 hour shift
Day shift
Work Location: In person