Cleaning Validation Engineer

Position Summary

The Cleaning Validation Engineer is responsible for developing, executing, and maintaining cleaning validation programs to ensure pharmaceutical manufacturing equipment is cleaned to regulatory and company standards. This role ensures that cleaning processes consistently remove residues of active ingredients, excipients, and cleaning agents to prevent cross‑contamination and maintain product quality. The Cleaning Validation Engineer works closely with Quality Assurance, Manufacturing, Engineering, and R&D teams.

Key Responsibilities

Cleaning Validation Program Management

• Develop and execute cleaning validation protocols, reports, and risk assessments in accordance with cGMP, FDA, EMA, and other regulatory guidelines.
• Establish scientifically justified acceptance criteria for residues and cleaning limits.
• Identify worst‑case product and equipment scenarios using toxicological, solubility, and analytical data.
• Perform and document visual inspection assessments and residue sampling (swab and rinse methods).

Execution & Data Analysis

• Coordinate validation activities with Manufacturing and QA to ensure proper execution during production campaigns.
• Analyze laboratory data for residuals testing and interpret results to determine cleaning process effectiveness.
• Investigate cleaning failures, deviations, and nonconformities; implement corrective and preventive actions (CAPAs).

Process & Equipment Support

• Partner with Engineering and Operations to optimize cleaning processes and support new equipment commissioning.
• Evaluate and qualify cleaning agents, detergents, and sanitizers.
• Support change control activities related to equipment modifications, new product introductions, or updated cleaning procedures.

Documentation & Compliance

• Write and maintain SOPs related to cleaning validation and verification programs.
• Ensure documentation meets global regulatory expectations, internal quality standards, and audit readiness.
• Participate in internal and external audits; serve as SME for cleaning validation topics.

Qualifications

Education

• Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field (Master’s preferred).

Experience

• 2–5+ years of experience in pharmaceutical, biotech, or regulated manufacturing industry.
• Strong understanding of cGMP, 21 CFR Part 211, EU Annex 15, PIC/S guidelines, and ICH Q7/Q9 principles.
• Experience with chromatography, microbiology, or analytical chemistry methods is a plus.

Skills & Competencies

• Knowledge of cleaning validation principles (MACO calculations, PDE-based limits, swab/rinse recovery studies).
• Strong technical writing and protocol/report development skills.
• Ability to analyze complex data and troubleshoot validation issues.
• Effective communication and cross-functional collaboration skills.
• Proficiency with validation lifecycle management systems and quality management systems (TrackWise, Veeva, etc. a plus).