Specialist Manufacturing – Cleaning Validation
Core
Technical lead for equipment cleanability and cleaning/sterilization validation in a multi-product biologics manufacturing environment.
Role type
Specialist Manufacturing – Cleaning Validation (Individual Contributor)
Builds
Validated cleaning and sterilization processes for drug substance manufacturing
Domain
Biopharmaceutical Manufacturing / GMP
Required skills
Cleaning validation strategy development, MAC/MAR calculations, cross-functional project leadership, GMP compliance, regulatory audit support, data analysis and trending, change control management, CAPA and deviation investigation, equipment qualification support, technical writing, mathematical modeling, Microsoft Excel proficiency
Preferred skills
Expertise in biologics facility cleanability, EudraLex Annex 15, FDA 21 CFR Parts 210/211, ASTM E2500, ICH Q7, on-floor troubleshooting, mentoring technical teams
Technologies
Microsoft Excel, GMP systems, validation software
Responsibilities
Own equipment cleanability assessments and validation requirements for NPIs and existing products; lead cross-functional projects from planning to implementation; provide on-floor technical support and troubleshooting; develop and approve validation protocols and sampling plans; assess validation impacts for process changes; maintain validation status and analyze routine monitoring data; represent the role during regulatory audits; mentor and train colleagues
Seniority
Specialist, hands-on IC
