Cleaning Validation Specialist

ProQuality Network; Indianapolis (IN); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

ProQuality Network is seeking a Cleaning Validation Engineer/Specialist to develop, execute, and maintain cleaning validation programs for pharmaceutical manufacturing. You will ensure removal of residues, cleaning agents, and contaminants to established criteria and collaborate with Analytical and Microbiology teams to meet GMP expectations.

The role involves designing strategies, risk assessments, sampling plans, and validation reports, while supporting regulatory inspections and continuous

Qualifications

• Bachelor’s degree in a relevant scientific/technical discipline.
• 3+ years in cleaning validation, process validation, or GMP manufacturing.
• Hands-on experience developing and executing cleaning validation protocols.
• Strong GMP knowledge and cleaning validation concepts.
• Experience with swab and rinse sampling techniques and strategies.
• Experience with risk assessments and worst-case product/equipment selection.
• Experience investigating deviations and failures in cleaning validation.
• Strong technical writing and documentation skills.
• Ability to work with Quality, Manufacturing, Engineering, Analytical, and Microbiology teams.

Responsabilités

• Develop and execute cleaning validation strategies, protocols, and reports for equipment and surfaces.
• Maintain Cleaning Validation Master Plans, risk assessments, SOPs, sampling plans, and reports.
• Identify worst-case products and equipment for cleaning validation based on multiple factors.
• Establish acceptance criteria for residues, cleaning agents, and microbiological contamination.
• Develop sampling plans and validate swab and rinse strategies.
• Coordinate sampling activities and ensure proper handling of samples.
• Work with Analytical and Microbiology teams to define analysis requirements.
• Evaluate results and determine if processes meet acceptance criteria.
• Support MACO calculations, residue limits, and CIP systems reviews.
• Assist root cause investigations, CAPA, and change control related to cleaning validation.
• Support periodic review and regulatory inspections with documentation.

Connaissances

Analytical ability

Problem solving

Technical writing

Cross-functional collaboration

GMP principles

Formation

Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, Microbiology, or related

Description du poste

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.