Cleaning Validation Specialist

CIS International • Vega Baja, PR

21h • 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. 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.

Requirements

• Education: Bachelor´s degree in Science - Chemistry, Microbiology, Engineering.
• Experience: 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.).
• Skills: 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