About this opportunity
Confidential lists this Cleaning Validation Engineer opportunity in township of chapel hill, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 & Strategy
Develop and maintain the Cleaning Validation Master Plan (CVMP) in alignment with FDA, ICH Q9, ASTM E2500, and EU Annex 1
Establish lifecycle validation strategies (Stages 1–3, including CPV)
Define MACO and PDE-based acceptance limits using risk- and toxicology-based approaches
Validation Execution & Technical Leadership
Author, 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 risk
Lead CQV activities for CIP, COP, parts washers, and manual cleaning systems
Cleaning Optimization & Troubleshooting
Optimize 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 CAPAs
Apply data-driven and DOE approaches to improve consistency and effectiveness
Compliance & Lifecycle Management
Ensure ongoing compliance through periodic review and trend analysis (TOC, conductivity, residues)
Support and represent cleaning validation during inspections and audits
Maintain inspection readiness through documentation, deviation, and CAPA management
Support change control and FMEA-based risk assessments
Collaboration & Training
Partner cross-functionally (Manufacturing, Quality, Engineering, Analytical, PM) to align strategies
Review GMP documentation (URS, FRS, P&IDs, equipment designs)
Train staff on cleaning procedures, inspection expectations, and sampling
Provide mentorship and technical leadership within the function
Standardization & Continuous Improvement
Develop and maintain SOPs, templates, and validation procedures
Drive standardization of cleaning validation practices
Implement improvements to enhance efficiency, consistency, and risk control
Supervisory responsibilities
May provide technical leadership and mentorship to junior validation engineers or contractors
Lead training initiatives related to cleaning validation processes and compliance
Key Relationships:
Manufacturing Operations
Quality Assurance & Quality Control
Analytical Development / Laboratories
Engineering & Facilities
Project Management
Regulatory Affairs
Clients / External Auditors
Travel requirements:
Minimal travel required;
occasional travel for client meetings, audits, or regulatory inspections
Education and Experience
Bachelor’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 environments
Strong experience in multi-product GMP manufacturing environments, preferably including topical, semi-solid, or aseptic/fill-finish operations
Demonstrated experience supporting regulatory inspections and lifecycle cleaning validation programs
Knowledge, Skills, and Abilities
Subject matter expertise in Cleaning Validation (CIP, COP, manual cleaning systems) and lifecycle validation
Strong knowledge of regulatory requirements (FDA, cGMP, ICH Q9, ASTM E2500, EU Annex 1, GAMP 5, ALCOA+)
Expertise in :
MACO & PDE calculations and toxicological risk assessments
Cleaning cycle development, optimization, and troubleshooting
Swab and rinse sampling strategies and recovery studies
Cross-contamination control strategies in multi-product facilities
Data 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 equipment
Strong technical writing skills for protocols, reports, and SOPs
Excellent problem-solving and root-cause analysis capabilities
Ability to manage multiple priorities in a fast-paced, growth-oriented environment
Strong communication and cross-functional collaboration skills
Physical Demands and Work Environment
While 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 environments
Occasional lifting of materials or equipment (up to 20 kg)
Exposure to GMP manufacturing areas including cleanrooms, laboratories, and production suites
May be exposed to varying temperatures, chemicals, and moderate noise levels in manufacturing settings
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The 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. xzgxqkn To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
Worksite address
township of chapel hill, NC, 27516, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.