Cleaning Validation Engineer

Position Summary –

The Cleaning Validation Engineer oversees the development, maintenance, and governance of Med Pharm’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 Med Pharm’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.

• 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

• May provide technical leadership and mentorship to junior validation engineers or contractors
• Lead training initiatives related to cleaning validation processes and compliance

• 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…