Cleaning Validation Specialist

Job Description

Job Description

LOCATION: Gurabo / Juncos / Las Piedras

Job Overview

We are seeking a Cleaning Validation Consultant to support a regulated manufacturing site in Puerto Rico. This role is fully on-site and will focus on planning, executing, and documenting cleaning validation activities to ensure compliance with FDA and international guidelines. The consultant will provide technical expertise in developing risk-based cleaning strategies and maintaining validated states for manufacturing and packaging equipment.

Main responsibilities:

• Develop and execute cleaning validation protocols and reports for production equipment and facilities.
• Review and maintain the Cleaning Validation Master Plan.
• Establish acceptance criteria, sampling plans, and worst-case product/equipment scenarios based on risk assessments.
• Collaborate with Quality, Engineering, Manufacturing, and Microbiology to ensure robust and compliant cleaning processes.
• Analyze cleaning validation data and recommend improvements to enhance control and reduce risk.
• Support regulatory inspections and internal audits as a subject matter expert.
• Ensure all validation documentation meets cGMP, FDA, EMA, and ICH standards.

General requirements:

• Fluency in Spanish and English (spoken and written)
• Strong technical writing and documentation skills.
• Proficiency in Microsoft Office 365 (Excel, Word, Power Point).
• Organizational skills, attention to detail, and ability to manage multiple tasks.
• Excellent communication skills.

Education Requirements:

• Minimum: Bachelor's degree in engineering, Life Sciences, Chemistry, Biology, or related field.
• A combination of education and relevant experience can be considered.

Experience Requirements:

• Minimum 5 years of experience in cleaning validation within pharmaceutical, biotech, or consumer health manufacturing.
• Strong knowledge of cGMP, FDA, EMA, and ICH Q7/Q8/Q9/Q10 guidance.
• Experience with risk-based cleaning validation approaches.
• Familiarity with manual and automated CIP/COP cleaning systems.

Physical requirements

• Ability to sit for long periods of time.
• Light physical activity may be required occasionally.
• You should be able to visit field locations as needed.
• Must be able to use personal protective equipment (PPE) when required.
• Ability to perform in diverse industrial environments.