• Legend Biotech USA, Inc. (Raritan, NJ)
    …of computer systems validation , equipment, utilities, and facility qualification, process validation , shipping validation , and data integrity.Key ... Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment, utilities, and facilities… more
    HireLifeScience (07/02/25)
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  • Vaxcyte (San Carlos, CA)
    …equality and clarity across communications and decision making. Summary: The Director, Process Validation and Risk Management has the accountability for: ... Commercial process validation of the Vaxcyte end -to-end processes Identification, assessment, and mitigation of operational, technical, and regulatory risks… more
    Upward (07/05/25)
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  • Merck & Co. (Durham, NC)
    …preparation for commercial production.- The selected candidate will participate in equipment validation , process validation , and GMP laboratory readiness.- ... Specialist, Quality Control participates in a team of analysts in the development, validation , and routine testing for the BCG Product. The position will focus on… more
    HireLifeScience (07/29/25)
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  • Repligen (Rancho Dominguez, CA)
    …bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes ... is highly desirable. Hands-on experience with: Tangential Flow Filtration (TFF) Process validation and equipment qualification Tech transfer between sites… more
    HireLifeScience (07/11/25)
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  • Insmed Incorporated (San Diego, CA)
    …material specifications, protocols and author development reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical ... Medium Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you… more
    HireLifeScience (07/14/25)
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  • Merck & Co. (Rahway, NJ)
    …commercialization and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation ... technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and… more
    HireLifeScience (07/17/25)
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  • Merck & Co. (Rahway, NJ)
    …Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, ... of biological molecules.Familiarity with late-stage process development, process characterization, process validation regulatory submissions,… more
    HireLifeScience (07/24/25)
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  • Merck & Co. (Rahway, NJ)
    …expected to apply their knowledge of product design and development, manufacturing process development, qualification, validation , and design control and risk ... deep knowledge in device design, requirement management, design verification, automation/ process development, design validation , human factors evaluations and… more
    HireLifeScience (07/29/25)
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  • Merck & Co. (Durham, NC)
    …assessments Author or approve Change Control documentation for complex process , validation , analytical, equipment, facility/utility and/or automation changes. ... and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process more
    HireLifeScience (07/23/25)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. ... electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with… more
    HireLifeScience (07/04/25)
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  • Merck & Co. (Rahway, NJ)
    …in design controls, risk analysis, control strategies, design verification testing, and process validation , with a strong understanding of quality management ... company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an… more
    HireLifeScience (07/19/25)
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  • Merck & Co. (Rahway, NJ)
    …experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation , filing and supply ... on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a… more
    HireLifeScience (07/26/25)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …combined experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a ... preference for Cell/Gene Therapy experienceMinimum of 5 years of experience of progressive leadership roles in a cGMP operation, with prior Biologics and/or cell therapy operations experience preferred.Prior experience leading large multilevel teams.A history… more
    HireLifeScience (07/26/25)
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  • Oxford Global Resources (Andover, MA)
    …packaging equipment and facilities/utilities supporting these operations Develop and execute process validation protocols for all manufacturing and packaging ... Summary: Prepare and execute cleaning, process and packaging validation , and equipment qualification plans and protocols. Write Final summary Reports that… more
    Upward (07/28/25)
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  • Merck & Co. (Rahway, NJ)
    …engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.)Must be innovative and drive new ideas, but also have pragmatic ... decisions standpoint.Experience in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is preferredFill/finish process scale-up, Drug Delivery… more
    HireLifeScience (07/24/25)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …representative for contractor services including design, fabrication, installation, and validation Point person for process improvement activities, including ... to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions… more
    HireLifeScience (05/17/25)
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  • Eisai, Inc (Exton, PA)
    …discretion.9. Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control, Validation , ... purification, biologics equipment operation, and CIP/SIP operations. Knowledgeable in process development, technology transfer, equipment scale-up, equipment validation more
    HireLifeScience (05/29/25)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    … improvements/cost reduction program into manufacturing Perform area equipment and process validations in accordance with validation procedures Perform in- ... of routine documentation associated with the manufacture of product Support in- process activities and product development when instructed by supervisor Incorporate… more
    HireLifeScience (07/09/25)
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  • Merck & Co. (Rahway, NJ)
    …Immunochemistry, Innovation, Laboratory Informatics, Liquid Chromatography (LC), Management Process , Matrix Management, Mentoring Staff, Method Validation ... and industrial standards of control strategy for residual HCPs and other process related impurities in biologics.A strong team player with excellent oral and… more
    HireLifeScience (07/24/25)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionTitle: Specialist, Metrology and Validation , Analytical Research & DevelopmentJob Description-The Analytical Research & Development (AR&D) External ... Capabilities, Validation , and Compliance (ECVC) department of our company's Research...inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here… more
    HireLifeScience (07/26/25)
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