Cleaning Validation Engineers

Responsibilities

• 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.
• Perform and document visual inspection assessments and residue sampling (swab and rinse methods).
• Coincide 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).
• Partner with Engineering and Operations to optimize cleaning processes and support new equipment commissioning.
• Support change control activities related to equipment modifications, new product introductions, or updated cleaning procedures.
• Write and maintain SOPs related to cleaning validation and verification programs.
• Ensure documentation meets global regulatory expectations, internal quality standards, and audit readiness.

Requirements

• Bachelor’s degree or higher in engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field.
• 4+ years of experience in the Biotechnology or Pharmaceutical industries.
• Strong knowledge and experience implementing 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, Kneat, Veeva, etc., a plus).