Cleaning Validation Specialist

• The Cleaning Validation Specialist (Contractor) will support the introduction of new products in a Contract Manufacturing Organization (CMO) environment.
• This role is responsible for developing and executing the full cleaning validation lifecycle, including:

• Risk assessments,
• Protocol development,
• Cleaning process definition,
• and contamination‑control strategies to ensure compliance with regulatory expectations (FDA, EMA, PIC/S, ICH) and internal quality standards.
• The specialist will collaborate with Manufacturing, Quality, Engineering, and Technical Services to ensure robust, science‑based cleaning validation aligned with product potency, toxicity, and cross‑contamination risks.
• Develop comprehensive cleaning validation protocols.
• Define and document acceptance criteria, including applicable calculations, limits, and analytical method requirements.
• Establish cleaning validation approaches and document them.
• Define and document the cleaning process parameters.
• Develop cleaning instructions SOP.
• Create or update forms, templates, and log sheets for cleaning execution, sampling, equipment release, deviations, and change control.
• If applicable, conduct a detailed cross-contamination risk assessment for product transfer between buildings considering product classification, facility design and material/personnel flows, etc. Identify potential contamination focus points and recommend appropriate cleaning validation controls.

• 5+ years of direct related experience in regulated manufacturing industries such as medical devices or pharmaceutical.
• Strong background in risk assessments, contamination control, and multi‑building manufacturing flows.
• Experience developing cleaning validation protocols, reports, and SOPs.
• Familiarity with analytical methods for cleaning validation (TOC, HPLC, UV, etc.).

• Strong understanding of GMPs and global regulatory expectations.
• Ability to interpret equipment design, P&IDs, and process flow diagrams.
• Excellent technical writing and documentation skills.
• Strong analytical and problem‑solving abilities.
• Effective communication and cross-functional collaboration.
• Ability to work independently and manage multiple priorities.

• Professional services contract
• Full on site job
• Full time assignment
• Location: Vega Baja, PR
• Administrative shift and wiling to provide services during non admin. hours, based on project needs
• 4 months of expected contract term

CIS International LLC