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    Job · 16876141

    Amneal Pharmaceuticals logo

    Sr Manager, Process Engineering

    Amneal Pharmaceuticals · Hyderabad · onsite · Posted 41d ago

    Undisclosed15–20 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Description:
    Ther role is accountable for leading the design, development, implementation, and optimization of pharmaceutical manufacturing processes to ensure efficient, economical, scalable, and compliant mass production. The role provides strategic direction across process design, equipment layout, scale-up, and validation activities while ensuring regulatory compliance and product quality. This position drives process robustness, risk management, and operational excellence across the product lifecycle. The role partners with Manufacturing, Quality, RD, and Engineering teams to enable technology transfer, continuous improvement, and data-driven decision-making. The role also ensures audit readiness, performance optimization, and sustainable manufacturing practices aligned with business and regulatory expectations.

    Essential Functions:
    • Lead process design, optimization, and manufacturing layout planning
    • Oversee process scale-up, technology transfer, and commercialization activities
    • Ensure regulatory compliance and GMP adherence across processes
    • Govern process validation strategies, IQ/OQ/PQ, and master plans
    • Drive deviation investigations, CAPA, and root cause analysis
    • Monitor process KPIs, yields, and performance metrics
    • Support equipment selection, installation, and automation integration
    • Lead risk management, FMEA, and safety assessments
    • Ensure quality, audit readiness, and inspection support
    • Mentor teams and enable training and competency development
    • Manage preventive maintece of critical process equipments: RMG/FB/Fluid Bed Processor, Blenders, CAD Mill, Compression, Encapsulation, Auto-coaters,
    • Vision/Checkweighers
    • Recommend vision systems and MES/eBR integration tools for process control
    • Support in investigations for blend uniformity, weight variation, lamination/capping, sticking/picking, dissolution failures, friability/coating defects
    • Approve equipment URS, FAT/SAT and support IQ/OQ/PQ from a process perspective


    Additional Responsibilities: Education:
    • Bachelors Degree (BA/BS) B.E. - Required
    • Master Degree (MS/MA) ME - Preferred
    Experience:
    • 15 years or more in 15+ Years
    Specialized Knowledge: Licenses:


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    AutomationCompressionmesintegration toolsbsEquipment SelectionCompetency developmentCAPACADEquipment layoutLayout PlanninglaminationMass ProductionFMEACappingManufacturingmaintenancecomplianceCoating

    About Amneal Pharmaceuticals

    Amneal Pharmaceuticals logo

    Amneal Pharmaceuticals

    Pharma

    5.5k+

    employees

    2002

    24 years old

    Bridgewater, New Jersey

    United States (USA)

    About

    Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.

    Industries

    PharmaBiotechnologyClinical Research

    Employee ratings

    1,455 reviews

    4.2/ 5

    Culture

    4.0

    Career growth

    3.5

    Work-life

    4.2

    Employees rate it well for

    Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65

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    Sr Manager, Process Engineering · waiting for your command