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