Cleaning Validation Engineer

Position Summary

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The Cleaning Validation Engineer oversees the development, maintenance, and governance of the company's site-wide cleaning validation program across the full product lifecycle, from development through commercialization, ensuring compliance with cGMP, FDA, and global regulatory requirements. Supporting the company's growth into a late-stage, commercialization-focused CDMO, this role provides technical leadership, risk-based strategy, and operational discipline to ensure inspection readiness, prevent cross-contamination in a multi-product environment, and optimize manufacturing throughput. The role serves as an SME in CIP, COP, and manual cleaning processes, driving robust, efficient, and compliant validation strategies aligned with client expectations and business growth.
Essential Functions
Cleaning Validation Program Ownership & StrategyDevelop and maintain the Cleaning Validation Master Plan (CVMP) in alignment with FDA, ICH Q9, ASTM E2500, and EU Annex 1Establish lifecycle validation strategies (Stages 1–3, including CPV)Define MACO and PDE-based acceptance limits using risk- and toxicology-based approachesValidation Execution & Technical LeadershipAuthor, review, and approve validation protocols and reports (including IQ/OQ/PQ as applicable)Design and execute validation studies (swab/rinse sampling, recovery studies, riboflavin coverage, CHT/DHT/CEHT)Develop risk-based sampling strategies and worst-case scenarios based on equipment and contamination riskLead CQV activities for CIP, COP, parts washers, and manual cleaning systemsCleaning Optimization & TroubleshootingOptimize cleaning cycles using key parameters (flow, temperature, detergent, contact time)Perform system performance analysis (spray coverage, flow distribution, conductivity return)Investigate failures (TOC, residues, riboflavin) and implement CAPAsApply data-driven and DOE approaches to improve consistency and effectivenessCompliance & Lifecycle ManagementEnsure ongoing compliance through periodic review and trend analysis (TOC, conductivity, residues)Support and represent cleaning validation during inspections and auditsMaintain inspection readiness through documentation, deviation, and CAPA managementSupport change control and FMEA-based risk assessmentsCollaboration & TrainingPartner cross-functionally (Manufacturing, Quality, Engineering, Analytical, PM) to align strategiesReview GMP documentation (URS, FRS, P&IDs, equipment designs)Train staff on cleaning procedures, inspection expectations, and samplingProvide mentorship and technical leadership within the functionStandardization & Continuous ImprovementDevelop and maintain SOPs, templates, and validation proceduresDrive standardization of cleaning validation practicesImplement improvements to enhance efficiency, consistency, and risk control
Supervisory responsibilitiesMay provide technical leadership and mentorship to junior validation engineers or contractorsLead training initiatives related to cleaning validation processes and compliance
Key Relationships:Manufacturing OperationsQuality Assurance & Quality ControlAnalytical Development / LaboratoriesEngineering & FacilitiesProject ManagementRegulatory AffairsClients / External Auditors
Travel requirements:Minimal travel required; occasional travel for client meetings, audits, or regulatory inspections
Education and ExperienceBachelor’s or Master’s degree in Engineering (Mechanical, Chemical, or related discipline)5–8+ years of experience in cleaning validation and CQV within pharmaceutical, biopharmaceutical, or CDMO environmentsStrong experience in multi-product GMP manufacturing environments, preferably including topical, semi-solid, or aseptic/fill-finish operationsDemonstrated experience supporting regulatory inspections and lifecycle cleaning validation programs
Knowledge, Skills, and AbilitiesSubject matter expertise in Cleaning Validation (CIP, COP, manual cleaning systems) and lifecycle validationStrong knowledge of regulatory requirements (FDA, cGMP, ICH Q9, ASTM E2500, EU Annex 1, GAMP 5, ALCOA+)
Expertise in:MACO & PDE calculations and toxicological risk assessmentsCleaning cycle development, optimization, and troubleshootingSwab and rinse sampling strategies and recovery studiesCross-contamination control strategies in multi-product facilitiesData analysis and trending (TOC, conductivity, residue monitoring)
Experience with:CIP system performance analysis (flow dynamics, spray coverage, conductivity return)Equipment qualification (IQ/OQ/PQ) and utilities (WFI, clean steam, HVAC)Cleaning validation for process, fill-finish, and packaging equipmentStrong technical writing skills for protocols, reports, and SOPsExcellent problem-solving and root-cause analysis capabilitiesAbility to manage multiple priorities in a fast-paced, growth-oriented environmentStrong communication and cross-functional collaboration skills
Physical Demands and Work EnvironmentWhile performing the duties of this job, there may be certain physical demands required for the position:May be required to stand for extended periods within manufacturing environmentsOccasional lifting of materials or equipment (up to 20 kg)Exposure to GMP manufacturing areas including cleanrooms, laboratories, and production suitesMay be exposed to varying temperatures, chemicals, and moderate noise levels in manufacturing settings
Other DutiesYou may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and DisclaimerThe above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. xzbcwsv To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.