Manager/Senior Manager, Process and Cleaning Validation
beam therapeuticsDurham, NC
Manager/Senior Manager, Process and Cleaning Validation
beam therapeuticsDurham, NC
yesterday
Industries
Research and Development in BiotechnologyBiological Product ManufacturingPharmaceutical Preparation ManufacturingAbout the role
Role:
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.
Requirements:
Bachelor'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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JOB OVERVIEW
Experience level
Manager
Location
Durham, NC
Occupation
Validation Engineers
Industry
Research and Development in Biotechnology
Posted
yesterday
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