Cleaning Validation Engineer

We are seeking an experienced Cleaning Validation Engineer to support cleaning validation activities within a GMP‑regulated pharmaceutical/biotechnology manufacturing environment. This role will be responsible for developing, executing, and maintaining cleaning validation programs to ensure manufacturing equipment and processes meet regulatory and quality requirements. Key Responsibilities Develop and execute Cleaning Validation protocols, reports, and risk assessments. Establish cleaning limits using MACO calculations and PDE‑based acceptance criteria. Perform swab and rinse sampling, recovery studies, and visual inspection assessments. Analyze validation and laboratory data to evaluate cleaning effectiveness. Investigate deviations, cleaning failures, and support CAPA activities. Collaborate with Manufacturing, Quality, and Engineering teams during validation execution. Support equipment commissioning, change controls, and new product introductions. Author and maintain SOPs, validation documentation, and audit‑ready records. Ensure compliance with cGMP, FDA, EMA, and internal quality requirements. Qualifications 4+ years of Cleaning Validation experience in Pharma or Biotech. Strong knowledge of Cleaning Validation lifecycle and regulatory expectations. Experience with MACO calculations, PDE limits, and recovery studies. Excellent technical writing, documentation, and problem‑solving skills. Experience with TrackWise, Kneat, Veeva, or similar quality systems is a plus. #J-18808-Ljbffr