Cleaning Validation Specialist (Holly Springs)

Key ResponsibilitiesDevelop, 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.QualificationsBachelors degree in Engineering, Life Sciences, or related field (Masters preferred).35+ 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.

Created: 2025-09-22