Cleaning Validation Engineer
Durham, NC
Full Time
Experienced
Position Summary – The Cleaning Validation Engineer oversees the development, maintenance, and governance of MedPharm’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 MedPharm’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
Supervisory responsibilities:
Key Relationships:
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position:
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. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
Supporting MedPharm’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
- 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
- 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
- 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
- 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
- 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
- Minimal travel required; occasional travel for client meetings, audits, or regulatory inspections
- 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
- 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. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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