Cleaning Validation Specialist

Location: Gurabo / Juncos / Las Piedras, Puerto Rico (On-Site)

Job Overview

We are seeking an experienced Cleaning Validation Specialist to support regulated pharmaceutical manufacturing operations in Puerto Rico. This role is fully on-site and will focus on the execution, documentation, and lifecycle management of cleaning validation activities for manufacturing equipment, utilities, and laboratory environments.

The ideal candidate will have strong experience in cleaning validation, including disinfectant and sanitization validation for Microbiology QC Laboratories and manufacturing areas, ensuring compliance with FDA and international regulatory requirements. This position requires expertise in developing validation strategies, performing risk assessments, and maintaining validated cleaning processes.

Main Responsibilities

• Develop, execute, and approve Cleaning Validation protocols, reports, and supporting documentation.
• Lead cleaning validation activities for manufacturing equipment, production areas, and process support equipment.
• Perform disinfectant and sanitization validation for Microbiology QC Laboratories and manufacturing environments.
• Validate cleaning agents, disinfectants, sanitization procedures, and environmental cleaning processes.
• Develop and maintain the Cleaning Validation Master Plan.
• Establish scientifically justified acceptance criteria, sampling plans, and worst-case product/equipment selection.
• Perform risk assessments to support cleaning validation strategies.
• Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams.
• Analyze validation data, investigate deviations, and recommend corrective actions when necessary.
• Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards.
• Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation.

General Requirements

• Fluency in English and Spanish (written and spoken).
• Strong technical writing and documentation skills.
• Excellent analytical and problem-solving abilities.
• Proficiency with Microsoft Office 365 (Excel, Word, PowerPoint).
• Strong communication and cross-functional collaboration skills.
• Ability to manage multiple validation projects simultaneously.
• Strong attention to detail and organizational skills.

Education Requirements

• Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life Sciences, or related discipline.
• Equivalent combination of education and relevant pharmaceutical experience may be considered.

Experience Requirements

• Minimum 2 years of pharmaceutical industry experience.
• Minimum 2 years of Cleaning Validation experience in FDA-regulated pharmaceutical, biotechnology, or medical device manufacturing.
• Hands-on experience developing and executing Cleaning Validation protocols and reports.
• Experience performing disinfectant validation and sanitization validation.
• Experience supporting Microbiology QC Laboratories (QC Micro) and manufacturing operations.
• Knowledge of cleaning process lifecycle and contamination control strategies.
• Experience performing risk assessments for cleaning validation.
• Strong understanding of cGMP regulations and FDA expectations.

Preferred Experience

• Experience with environmental monitoring programs.
• Experience validating cleaning procedures for aseptic or sterile manufacturing.
• Experience with CIP (Clean-In-Place) and COP (Clean-Out-of-Place) systems.
• Familiarity with TOC, conductivity, swab sampling, rinse sampling, and recovery studies.
• Experience supporting regulatory inspections.

Physical Requirements

• Ability to sit for extended periods.
• Occasional standing and walking throughout manufacturing and laboratory areas.
• Ability to wear required Personal Protective Equipment (PPE).
• Ability to access manufacturing, laboratory, and controlled environments.
• Ability to perform work in regulated industrial environments.