Technician II - Tech Services

Bora Pharmaceuticals

  • Maple Grove, Minnesota
  • 20 days ago
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    Skills

    • Biotech and Pharmaceuticalunmatched
    • Chemistryunmatched
    • Cleaning Equipmentunmatched
    • Clinical Supportunmatched
    • Contract Manufacturingunmatched
    • Cross-Functionalunmatched
    • Datasheetsunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • Drug Developmentunmatched
    • Drug Productsunmatched
    • Equipment Maintenance/Repairunmatched
    • Equipment Validationunmatched
    • High School Diplomaunmatched
    • Identify Issuesunmatched
    • Inventory Reportsunmatched
    • Laboratory Notebookunmatched
    • Manufacturingunmatched
    • Organizational Skillsunmatched
    • Process Validationunmatched
    • Product Managementunmatched
    • Product Testingunmatched
    • Quality Assuranceunmatched
    • Quality Engineeringunmatched
    • Record Keepingunmatched
    • Technical Leadershipunmatched
    • Technical Operationsunmatched
    • Technical Services Managementunmatched
    • Technical Supportunmatched
    • Technical Writingunmatched
    • Testingunmatched
    • Time Managementunmatched
    • Validation Documentationunmatched
    • Validation Testingunmatched
    • Writing Skillsunmatched

    Description

    About Bora

    Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

    Job Summary

    The Technician II – Technical Services supports the Technical Services department through hands-on operation, setup, cleaning, and organization of equipment within the development suites. This role supports development suite activities and provides technical support for development, technology transfer, registration/submission, validation, and commercial manufacturing activities for CDMO clients. The position assists with batch manufacture, equipment readiness, physical testing, cleaning validation, documentation, and cross-functional support to Manufacturing, Quality, Engineering, Maintenance, EHS, and other departments as needed.

    Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

    This role requires to be onsite

    Essential Job Functions

    • Maintains readiness of the development suites, including equipment setup, operation, cleaning, room organization, change parts, spare parts, supplies, and general area upkeep.
    • Maintains, operates, cleans, and supports setup/changeover of development suite equipment used for blending, dry and wet granulation, drying, milling, compression, coating, encapsulation, and other oral solid dosage and liquid unit operations, as applicable.
    • Coordinates with Engineering, Maintenance, EHS, and other departments to support equipment repairs, calibrations, containment requirements, and development suite readiness.
    • Prepares experimental, laboratory, and development batches within the development suites and assists with documentation, sampling, process observations, troubleshooting, and technical support for clinical, registration/submission, validation, and commercial manufacturing batches of new or existing products under the supervision of Technical Services Scientists.
    • Performs sampling and physical testing of products, including but not limited to: disintegration, hardness and friability of tablets, particle size, flow characteristics, and moisture of granulations and powders.
    • Maintains accurate records, including laboratory notebooks, batch record documentation, experimental data sheets, training records, and supply inventories within the development suites.
    • Assists with writing, reviewing, and revising equipment procedures, cleaning procedures, batch records, protocols, reports, and other technical documentation.
    • Assists in the execution and documentation of validation and qualification activities, including cleaning validation swabbing, process validation support, packaging validation support, equipment qualification, and facilities/systems qualification activities, as needed.
    • Supports technology transfer activities by assisting with process execution, sampling, documentation, process observations, and troubleshooting during development, clinical, registration/submission, validation, and commercial manufacturing batches.
    • Provides technical support to Operations, Quality Assurance, and other departments as needed.
    • Assists in the training of technicians.

    The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.  

    Education & Experience Requirements

    Two years of college or vocational education, preferably in chemistry, engineering, or a health-related field and a minimum of one year of technical service or development experience; OR a high school diploma / GED with four or more years of pharmaceutical experience.

    Knowledge of current Good Manufacturing Procedures, ability to follow written procedures, attention to detail, strong organizational skills, and ability to accurately document observations and test results.

    Compensation Range

    $52,000 - $68,000

    Compensation and Benefits

    We offer a comprehensive benefits package designed to support our employees’ wellbeing, including:

    • Competitive salary and performance-based incentives

    • Comprehensive health coverage including medical, dental, and vision insurance

    • Retirement savings plans with employer matching contributions

    • Paid time off

    • Professional development opportunities

    • Employee wellness programs and resources

    • Employee Assistance Program and Mental Health Resources

    Core Values

    At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

    Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals  will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

    Numbers & Facts

    LocationMaple Grove, Minnesota

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