Job Description

Key Responsibilities

• Develop, execute, and maintain cleaning validation protocols, reports, and SOPs for biologics manufacturing equipment (upstream, downstream, and support systems).
• Perform risk assessments and establish acceptance criteria for cleaning validation per FDA, EMA, and ICH guidelines.
• Collaborate with Manufacturing, QA, QC, and Engineering to ensure timely execution of cleaning validation and verification activities.
• Support investigations related to cleaning deviations, OOS results, and non-conformances.
• Participate in equipment commissioning and qualification to ensure cleaning considerations are included.
• Trend and analyze cleaning validation data and support continuous improvement initiatives.
• Ensure documentation is accurate, audit-ready, and aligned with site/global standards.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
• 3–5+ years of cleaning validation experience in a cGMP-regulated biopharma/biologics or CDMO environment.
• Strong understanding of regulatory expectations (FDA, EMA, WHO) for cleaning validation, including MACO calculation, worst-case product selection, and PDE limits.
• Hands-on experience with biologics manufacturing equipment (bioreactors, chromatography skids, filtration systems).
• Strong technical writing and documentation skills.

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