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    Quality Engineering Manager - Indiana, United States - Harba Solutions Inc.

    Harba Solutions Inc.
    Harba Solutions Inc. Indiana, United States

    2 weeks ago

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    Description

    Job Responsibilities:

    • Instrumentation Program Management: Develop and implement an instrumentation program to manage the calibration, qualification, and maintenance of analytical instruments and equipment used in pharmaceutical manufacturing and quality control laboratories.
    • Calibration and Qualification: Oversee the calibration and qualification of analytical instruments and equipment in accordance with regulatory requirements, industry standards, and internal procedures, ensuring accuracy, reliability, and compliance.
    • Instrumentation Maintenance: Develop and implement preventive maintenance schedules and procedures for analytical instruments and equipment to ensure optimal performance, reliability, and uptime, minimizing downtime and disruptions to production and testing activities.
    • Instrumentation Validation: Coordinate and support the validation of new analytical instruments and equipment, ensuring compliance with regulatory expectations and validation protocols (e.g., IQ/OQ/PQ), and facilitating the timely implementation and qualification of new instrumentation.
    • Change Control Management: Manage change control processes related to analytical instrumentation, including assessing proposed changes, evaluating potential quality impacts, and ensuring appropriate documentation, validation, and approval in accordance with established procedures.
    • Quality Control Testing Support: Provide technical support and troubleshooting assistance to quality control laboratories for instrumentation-related issues, ensuring timely resolution of problems and deviations to minimize impact on testing activities and product release timelines.
    • Documentation and Record Keeping: Maintain accurate and complete documentation and records related to instrumentation calibration, qualification, maintenance, and validation activities, ensuring compliance with regulatory requirements and data integrity principles.
    • Supplier Management: Collaborate with procurement and supplier management teams to select, qualify, and manage suppliers of analytical instruments and equipment, ensuring compliance with quality standards, specifications, and service requirements.
    • Training and Development: Provide training and technical guidance to instrumentation specialists and laboratory personnel on proper instrument operation, maintenance, calibration, and troubleshooting procedures to ensure competency and compliance with quality standards.
    • Continuous Improvement: Identify opportunities for process optimization, efficiency improvements, and cost savings related to instrumentation management and support functions, and implement appropriate corrective and preventive actions to drive continuous improvement.
    • Regulatory Compliance: Ensure compliance with regulatory requirements from agencies such as the FDA, EMA, and other global regulatory authorities related to instrumentation calibration, qualification, validation, and maintenance activities.

    Qualifications:

    • Bachelor's degree in engineering, chemistry, pharmaceutical sciences, or a related field required; advanced degree (e.g., Master's, MBA) preferred.
    • Significant experience in instrumentation management or related roles within the pharmaceutical or biotechnology industry, with a strong understanding of analytical instrumentation, calibration, qualification, and maintenance practices.
    • Knowledge of regulatory requirements, quality systems, and industry standards (e.g., cGMP, USP, EP) governing analytical instrumentation in the pharmaceutical industry.
    • Demonstrated leadership experience, with the ability to effectively lead, mentor, and develop a team of instrumentation specialists.
    • Strong analytical, problem-solving, and decision-making skills, with the ability to drive data-driven insights and actions to improve instrumentation performance and compliance.
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