The Cleaning Validation Specialist ensures that all cleaning processes for equipment, utensils, and manufacturing areas consistently remove residues to safe, compliant levels, meeting FDA, EMA, and GMP regulations. The role blends technical execution, documentation, risk assessment, and cross‑functional coordination.
The Cleaning Validation Specialist is responsible for developing, executing, and maintaining the site’s cleaning validation and verification program. This includes writing protocols, performing sampling, analyzing data, establishing acceptance criteria, and ensuring compliance with regulatory requirements. The specialist supports new product introductions, equipment changes, and continuous improvement initiatives related to cleaning processes.
Main responsibilities:
Develop, review, and approve Cleaning Validation Master Plans (CVMP), protocols, and final reports.
Conduct risk assessments to determine worst‑case product, equipment grouping, and cleaning strategy.
Establish and justify acceptance criteria for residues (API, detergents, bioburden, endotoxins).
Perform or coordinate swab and rinse sampling, ensuring proper technique and documentation.
Support laboratory testing for residue analysis and interpret analytical results.
Maintain validated state of cleaning processes through periodic review, revalidation, and change control.
Collaborate with Manufacturing, Engineering, QA, and QC to ensure cleaning procedures are robust and compliant.
Participate in root cause investigations related to cleaning failures or deviations.
Support new equipment qualification, product transfers, and introduction of new cleaning agents.
Ensure cleaning procedures (SOPs) reflect validated parameters and are aligned with best practices.
Prepare documentation for regulatory inspections and respond to auditor inquiries.
Monitor industry trends and regulatory updates to maintain a state of compliance.
Requirements:
Bachelor’s degree in Chemistry, Microbiology, Engineering, or related sciences.
3–5 years of experience in pharmaceutical, biotech, or medical device cleaning validation.
Strong knowledge of GMP, FDA, and data integrity principles.
Experience with residue limits calculations, MACO, PDE, and health‑based exposure limits.
Hands-on experience with swab/rinse sampling, analytical methods (HPLC, TOC), and equipment cleaning processes.
Work Methodology:
Founded on November 2010, CIS International is servicing companies within the Medical Device, Pharmaceutical, Biotechnology, Food and Beverage, Chemical, Manufacturing industry, and others.
As part of our process of adaptation to the changes that the market represents, our company has been studying the international market for approximately 3 years. With this, we seek to support new and existing customers outside Puerto Rico, such as the United States, India and Dominican Republic.
