Manager/Senior Manager, Process and Cleaning Validation
Listed on 2026-10-06
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Engineering
Regulatory Compliance Specialist, Quality Engineering, Pharma Engineer -
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Manage and lead process and cleaning validation programs for biopharmaceutical manufacturing, supporting early-stage process validation strategies.
Responsibilitiesdevelop validation master plans, protocols, and reports; conduct risk assessments and gap analyses; evaluate equipment and process procedures; support regulatory submissions and inspection readiness; train personnel; author and review validation documentation; oversee 3-5 validation team members including contractors; escape technical or schedule issues.
RequirementsBachelor's in Engineering, Chemistry, or related; 8+ years supporting biopharma manufacturing validation, with experience in process validation, cleaning validation, or process engineering; strong project management and technical documentation skills; team leadership experience.
Preferredexperience with LNP processes/equipment; knowledge of FDA, EMA, ICH validation guidelines; understanding of process design, CIP/COP systems, and analytical validation; familiarity with statistical validation methods; proficiency with Smartsheets.
TravelTravel: up to 25%.
Work setupWork setup not specified.
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