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    Aseptic Technician I - Indianapolis, United States - BioLife Solutions

    BioLife Solutions
    BioLife Solutions Indianapolis, United States

    3 weeks ago

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    Description

    Job Description

    Job DescriptionSalary: DOE + Excellent Benefits

    BioLife Solutions is repeatedly named one of Washington's 100 Best Companies to Work For, a list curated by Seattle Business Magazine. We welcome you to apply to join our dynamic, high-energy team. Here you will find a performance-based, family-oriented environment where authentic communication and treating colleagues with respect are required. Our employees receive a competitive benefits package, which includes generous company stock awards and a 401k matching program.

    BioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined CryoStor freeze media and HypoThermosol shipping and storage media, ThawSTAR family of automated, water-free thawing products, evo cold chain management system, and Custom Biogenic Systems high-capacity storage freezers. Services include SciSafe biologic and pharmaceutical materials storage. For more information, please visit:

    General Summary and Purpose:
    Daily production including environmental monitoring, formulating, and filling of aseptic GMP manufactured
    products according to batch records and SOPs. This position is entry level and an effective way to get started in a
    fast-growing company that is the leading cell preservation specialist within the fields of biotechnology and
    pharmaceuticals. This position allows for exposure to many department's ways of working and opportunities for
    cross functional projects. Allows for insight into the world of biotechnology.

    Duties and Responsibilities:

    • 90-95% of job duties will be directly related routine processes of manufacturing, filling, and
      packaging of Quality System regulated compliant media products. This includes but is not limited to:
    • Working inside cleanroom suites on your feet for several hours at a time
    • Perform environmental monitoring
    • Checking raw materials to ensure batches manufactured contain proper materials and
      quantities
    • Aseptically fill into finished product containers under sterile conditions
    • Perform cleaning of equipment and classified cleanrooms facility (ceiling, walls, critical
      surfaces,
      and floors)
    • Performing repetitive tasks while gowned (hood, mask, coveralls, boots, gloves, etc.)
    • Operate equipment such as balances, peristaltic pumps, filters, pH meter, and pipettes
    • Perform all tasks while follow all SOPs, batch records, and safety policies
    • Accurately complete batch record documentation, all appropriate logbook entries, and GMP
      documentation
    • Participate in process monitoring and improvement activities as needed
    • Participate in risk management activities
    • Assist in process deviation investigations

      • 5-10% of job duties will include indirect manufacturing support projects. This includes but is not
      limited to:
    • Perform preventive maintenance on manufacturing equipment
    • Perform tasks that contribute to process improvements.
    • Other projects and duties as required.

      • May be required to work either day or evening shift as needed.

      • May occasionally be required to work weekends and overtime as needed.

      • Required to be on-call for equipment monitoring on a rotation.

      • Duties, responsibilities, and activities may change at any time with or without notice.

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or
    responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at
    any time with or without notice.

    Reporting Relationships:
    This position reports to MSAT Manager

    Job Requirements:

    • Relevant life sciences manufacturing experience and familiarity with aseptic processes in a cGMP/FDA
      regulated environment, and/or two years of college-level science coursework with an interest in
      pharmaceutical manufacturing
    • Self-motivated and willing to accept temporary responsibilities outside of normal job duties
    • Comfortable working in a fast-changing small company environment and able to adjust work load based
      on changing priorities
    • Must not have unusual sensitivity to typical laboratory chemicals (i.e. sanitization agents)
    • Must be able to perform fast paced operations and repeatedly perform multi-step simultaneous
      operations with a high degree of accuracy
    • Effectively communicate while wearing cleanroom gowning (mask, hood, coveralls, gloves, etc.)
    • Must be able to work effectively in a group and independently
    • Must be able to meet aseptic gowning qualification requirements
    • Must be able to work regularly with cleaners
    • Must be able to lift up to 30 lbs. and push/pull up to 1200 lbs. with assistance
    • Software Used: Microsoft Office programs (Word, Excel, Outlook) is required

    Job Specifications:

    • Education Minimum: Two years of college-level biological coursework, i.e. in Chemistry, Biology,
      Physics, etc. or one year experience working in a GMP Manufacturing setting is required.
    • Experience Requirement Minimum: Prior aseptic gowning and processing techniques is desirable.
    • Knowledge of Lean/Six Sigma/5S a plus.

    BioLife Solutions provides a substance-free workplace, and all offers of employment will be contingent on opiate drug test and background check.

    BioLife Solutions is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

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