Position Summary

The Cleaning Validation Engineer/Specialist is responsible for developing, executing, and maintaining cleaning validation programs for pharmaceutical and/or biopharmaceutical manufacturing operations. This role ensures that cleaning processes consistently and effectively remove product residues, cleaning agents, and microbiological contaminants to established and scientifically justified acceptance criteria.

Key Responsibilities

• Develop and execute cleaning validation strategies, protocols, and reports for manufacturing equipment, systems, and product-contact surfaces.
• Develop and maintain cleaning validation lifecycle documentation, including:
• Cleaning Validation Master Plans/Strategies
• Risk Assessments
• Cleaning Procedures/SOPs
• Sampling Plans
• Validation Protocols
• Validation Reports
• Continued Process Verification/Periodic Review documentation
• Identify and evaluate worst-case products and equipment for cleaning validation based on factors such as solubility, potency, toxicity, cleanability, batch size, therapeutic dose, and equipment characteristics.
• Establish scientifically justified cleaning acceptance criteria, including limits for product residues, cleaning agents, and microbiological contamination.
• Develop and execute cleaning validation protocols, including appropriate swab and rinse sampling strategies.
• Determine and document sampling locations based on equipment design, product-contact surfaces, difficult-to-clean areas, and potential worst-case locations.
• Coordinate and/or execute cleaning validation sampling activities and ensure samples are properly collected, identified, handled, and submitted for analysis.
• Work with Analytical and Microbiology teams to establish appropriate analytical methods and testing requirements for cleaning validation samples.
• Evaluate analytical results and determine whether cleaning processes meet established acceptance criteria.
• Perform and document cleaning validation calculations, including residue limits and recovery considerations.
• Support determination and validation of Maximum Allowable Carryover (MACO) and other applicable residue limits.
• Evaluate cleaning processes for manual, automated, and Clean-in-Place (CIP) systems.
• Review equipment design, process flow diagrams, cleaning procedures, and equipment-specific documentation to identify cleaning challenges and validation requirements.
• Support cleaning process development and optimization, including evaluation of cleaning agents, concentrations, temperatures, contact times, flow rates, and other critical cleaning parameters.
• Conduct or support cleaning validation risk assessments and identify critical cleaning parameters and critical process variables.
• Investigate cleaning validation failures, deviations, atypical results, and out-of-specification results.
• Support root cause investigations and development of appropriate CAPA and corrective actions.
• Support change control assessments to determine the impact of changes to products, equipment, cleaning agents, cleaning procedures, or manufacturing processes on the validated cleaning state.
• Support periodic review and ongoing monitoring of validated cleaning processes.
• Review and approve technical documentation associated with cleaning validation activities.
• Work closely with Manufacturing and Operations personnel to ensure cleaning procedures are practical, reproducible, and consistently executed.
• Support regulatory inspections and internal audits by providing cleaning validation documentation and technical justification.
• Ensure all cleaning validation activities are performed and documented in accordance with applicable GMP requirements, site procedures, and regulatory expectations.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, Microbiology, or a related scientific/technical discipline.
• 3+ years of experience in cleaning validation, process validation, equipment validation, or a related function within a pharmaceutical, biotechnology, or other GMP-regulated manufacturing environment.
• Demonstrated hands-on experience developing and executing cleaning validation protocols.
• Strong understanding of GMP principles and cleaning validation concepts.
• Experience with swab and rinse sampling techniques and cleaning validation sample strategies.
• Experience with cleaning validation risk assessments and worst-case product/equipment selection.
• Experience investigating cleaning validation deviations and failures.
• Strong technical writing and documentation skills.
• Strong analytical, organizational, and problem-solving skills.
• Ability to work effectively with Quality, Manufacturing, Engineering, Analytical, and Microbiology teams.

Core Competencies

• Cleaning Validation
• Cleaning Process Development
• Swab & Rinse Sampling
• CIP Validation
• Risk Assessment
• GMP Documentation
• Deviations & CAPA
• Root Cause Investigation
• Cross-Functional Collaboration

Work Authorization:

Candidates must be legally authorized to work in the United States. This position is not eligible for employment visa sponsorship now or in the future.