Cleaning Validation Specialist Job at Unicon Pharma Inc, Holly Springs, NC

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  • Unicon Pharma Inc
  • Holly Springs, NC

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.

Job Tags

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