Cleaning Validation Specialist

CIS International • Vega Baja, PR

6d • Onsite

About The Position

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.

Requirements

• Bachelor´s degree in Science - Chemistry, Microbiology, Engineering.
• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level