Talent.com
Aseptic Manufacturing

Aseptic Manufacturing

Biocon BiologicsBengaluru, Karnataka, India
17 days ago
Job description

Biocon Biologics is a fully integrated ‘pure play’ biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.

Position : - Aseptic Manufacturing

Experience : - 12 to 14 Years of Experiences

Key Responsibilities

1. Compliance & Documentation

  • Follow current Good Manufacturing Practices (cGMP) and ensure all activities are documented online and in real-time.
  • Ensure Good Documentation Practices (GDP) are followed for all records, logbooks, and checklists.
  • Adhere to entry and exit procedures for aseptic and controlled areas as per SOP.
  • Update status boards and maintain accurate online entries in BMRs and logs.

2. Environmental Monitoring & Equipment Handling

  • Monitor and record temperature, differential pressure, UV lamp hours, and LAF readings as per defined frequency.
  • Perform fogging, cleaning, and maintenance of aseptic, sealing, and sterile corridor areas.
  • Operate, clean, and maintain aseptic area equipment such as vial / cartridge filling machines, sealing machines, lyophilizers, LAFs, pass boxes, and garment cubicles per SOP.
  • Coordinate preventive maintenance and calibration of instruments and equipment with maintenance / instrumentation teams.
  • 3. Aseptic Operations

  • Follow aseptic practices and behaviors in the sterile area at all times.
  • Perform solution filtration, capsule filter integrity testing, and aseptic connections as per SOP.
  • Conduct vial / cartridge filling and sealing operations for liquid and lyophilized products.
  • Carry out machine assembly, changeover, and troubleshooting during operations.
  • Load and unload vials in / from lyophilizer and autoclave as required.
  • 4. Process & Quality Assurance

  • Perform filled volume checks and gas purging entries as per BMR / SOP.
  • Ensure filled and sealed containers are transferred to the packing area or cold room as applicable.
  • Participate in Aseptic Process Simulation (Media Fill) and gowning requalification as per plan.
  • Provide personnel monitoring samples (finger dab / gown) to microbiology after operations.
  • Carry out non-viable particle count as per defined frequency.
  • Execute development batches in coordination with R&D.
  • 5. Safety & Training

  • Report any incidents, deviations, or accidents immediately to the supervisor.
  • Participate in cGMP, SOP, BMR, protocol, and other required trainings and maintain updated training records.
  • Create a job alert for this search

    Manufacturing • Bengaluru, Karnataka, India

    Related jobs
    • Promoted
    Manufacturing Execution System (AVEVA / Wonderware) Consultant

    Manufacturing Execution System (AVEVA / Wonderware) Consultant

    Tata Consultancy ServicesBengaluru, Karnataka, India
    We are hiring for Manufacturing Execution System (AVEVA / Wonderware) Consultant.Experience and technical knowledge with AVEVA MES solutions. Strong Experience on Development / Customizations / Enhanc...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    SAP Engineer

    SAP Engineer

    RELIANCE BEVERAGES PRIVATE LIMITEDBengaluru, Karnataka, India
    The SAP Engineer is responsible for designing, configuring, and supporting SAP modules that enable efficient execution of engineering and capital projects in the food and beverage sector.This role ...Show moreLast updated: 13 hours ago
    • Promoted
    • New!
    Emulation Engineer

    Emulation Engineer

    Eximietas DesignGreater Bengaluru Area, India
    Hands-on experience in SoC-level FPGA prototyping, design, and verification.Execute FPGA Bring up on industry-standard FPGA Prototyping systems like Synopsys HAPS. Strong knowledge of emulation plat...Show moreLast updated: 1 hour ago
    • Promoted
    • New!
    Emulation engineer

    Emulation engineer

    CapgeminiGreater Bengaluru Area, India
    Location : Bangalore and chennai.We are looking for an experienced.SoC Pre / Post Silicon Validation Engineer.ARM-based System-on-Chip validation. The ideal candidate will have hands-on experience in pr...Show moreLast updated: 3 hours ago
    • Promoted
    Aseptic Manufacturing

    Aseptic Manufacturing

    Biocon BiologicsBengaluru, Karnataka, India
    It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd...Show moreLast updated: 17 days ago
    • Promoted
    • New!
    Deputy Manager - Medical Devices Process development

    Deputy Manager - Medical Devices Process development

    Biocon BiologicsGreater Bengaluru Area, India
    Role Summary : Medical Devices Process development.Responsible for leading the development and optimization of manufacturing processes for new drug delivery devices and combination products.This ro...Show moreLast updated: 3 hours ago
    • Promoted
    • New!
    F5 Engineer

    F5 Engineer

    CACI LtdGreater Bengaluru Area, India
    CACI International Inc is an American multinational professional services and information technology company headquartered in Northern Virginia. CACI provides expertise and technology to enterprise ...Show moreLast updated: 3 hours ago
    • Promoted
    Production Engineer

    Production Engineer

    Apna Technologies & Solutions (ApnaTech)Hosur, Tamil Nadu, India
    Engineer is required to work, supervise and organize daily work on Production Floor.They are in control of all Sub Component Assembly, Part / Integrated Testing, Day-to-day production operations, inc...Show moreLast updated: 12 days ago
    • Promoted
    DFT Engineer

    DFT Engineer

    L&T Semiconductor TechnologiesBengaluru, Karnataka, India
    Purpose of the Role : The Design for Testability (DFT) engineering organization at L&T Semiconductor Technologies (LTSCT) pioneers innovative methods and technologies in the areas of DFT architectu...Show moreLast updated: 7 days ago
    • Promoted
    Manufactuiring Partners

    Manufactuiring Partners

    Indra Hydro Tech Pumps Pvt. Ltd. - IndiaBengaluru, Karnataka, India
    We are planning to start a company in.Please drop your details in the comments or send me a message.Would love to connect with experts who have worked with Centrifugal Pump Insustry.We are open to ...Show moreLast updated: 6 days ago
    • Promoted
    • New!
    Opcenter Core & Electronics (Camstar) MES Expert - Location : Pune, Mumbai, Bangalore

    Opcenter Core & Electronics (Camstar) MES Expert - Location : Pune, Mumbai, Bangalore

    Capgemini EngineeringGreater Bengaluru Area, India
    The Opcenter Core & Electronics (Camstar) MES Expert will be responsible for the plan, design, configuration, development, and testing of the Opcenter application. This role will work closely with t...Show moreLast updated: 1 hour ago
    • Promoted
    AM Manufacturing Operations

    AM Manufacturing Operations

    ConfidentialBengaluru / Bangalore
    Operational Leadership & Team Management.Provide leadership and supervision to the operations team, ensuring high levels of performance and service to customers while maximizing output and minimizi...Show moreLast updated: 17 days ago
    • Promoted
    EPS – Column & I-shaft

    EPS – Column & I-shaft

    Nexteer Automotive - India Technical CenterBengaluru, Karnataka, India
    Project customer requirements into BOM, drawings, specifications, DFMEA etc.Design and develop steering column products that adhere to industry best practices and as per customer requirements.Desig...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Factory Solutions Manager

    Factory Solutions Manager

    Tata ElectronicsGreater Bengaluru Area, India
    Electronics Manufacturing Services, Semiconductor Assembly & Test, Semiconductor Foundry, and Design Services.Established in 2020 as a greenfield venture of the Tata Group, the company aims to serv...Show moreLast updated: 3 hours ago
    • Promoted
    Aseptic Manufacturing

    Aseptic Manufacturing

    ConfidentialBengaluru / Bangalore, India
    It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd...Show moreLast updated: 11 days ago
    • Promoted
    Engineer - Databases [Returnship Program]

    Engineer - Databases [Returnship Program]

    KenvueNelamangala, Karnataka, India
    Kenvue is currently recruiting for a : .Engineer - Databases [Returnship Program].At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in sc...Show moreLast updated: 3 days ago
    • Promoted
    Manufacturing Engineer

    Manufacturing Engineer

    SafranBengaluru, Karnataka, India
    BE / Btech Electonics & communication, Electrical & Electronics / Instrumentation.Develop standard manufacturing methods for aerospace mechanical and electrical system assembly and integration.Prepare...Show moreLast updated: 17 days ago
    • Promoted
    Sr. Engineer (MS Fabric Migration & Development)

    Sr. Engineer (MS Fabric Migration & Development)

    Innover DigitalBengaluru, Karnataka, India
    Hands-on Migration and Development.Directly develop and migrate 20+ complex data pipelines from Azure Data Factory (ADF) into optimized Fabric Data Pipelines and Spark Notebooks (PySpark / Scala).Rew...Show moreLast updated: 18 days ago