Pharma Cleaning Validation Lead

Legalpmpartners; Caguas (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Legalpmpartners is seeking an experienced Cleaning Validation Specialist for an on-site role in Puerto Rico. You will support regulated pharmaceutical manufacturing by executing, documenting, and lifecycle-managing cleaning validation activities across equipment, utilities, and labs.

The ideal candidate brings strong cleaning validation expertise, regulatory knowledge, and the ability to develop strategies, perform risk assessments, and maintain validated cleaning processes in a GMP environment.

Qualifications

• Bachelor's degree in a relevant science/engineering field or equivalent pharma experience.
• 2+ years in pharma, with cleaning validation experience preferred.
• Experience developing and executing Cleaning Validation protocols and reports.
• Knowledge of cGMP, FDA expectations, and regulatory inspections.

Responsibilities

• Develop, execute, and approve Cleaning Validation protocols and reports.
• Lead cleaning validation activities for manufacturing equipment and facilities.
• Perform disinfectant and sanitization validation for Microbiology QC labs and manufacturing areas.
• Validate cleaning agents, disinfectants, sanitization procedures, and environmental cleaning processes.
• Maintain the Cleaning Validation Master Plan and establish acceptance criteria and sampling plans.
• Perform risk assessments to support cleaning validation strategies.
• Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams.
• Analyze validation data, investigate deviations, and implement corrective actions.

Skills

Cleaning validation

Regulatory compliance

Technical writing

Cross-functional collaboration

Microsoft Office 365

Bilingual EN/ES

Education

Bachelor's degree in Engineering/Chemistry/Biology/Pharma

Tools

CIP/COP systems

Job description

Legalpmpartners is seeking an experienced Cleaning Validation Specialist for an on-site role in Puerto Rico. You will support regulated pharmaceutical manufacturing by executing, documenting, and lifecycle-managing cleaning validation activities across equipment, utilities, and labs.

The ideal candidate brings strong cleaning validation expertise, regulatory knowledge, and the ability to develop strategies, perform risk assessments, and maintain validated cleaning processes in a GMP environment.