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    Process/Validation Engineer - Durham, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Durham, United States

    2 weeks ago

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    Description
    Responsibilities:
    • Validation Planning: Develop and implement validation strategies, including process, equipment, and cleaning validation, in compliance with FDA and international regulatory guidelines.
    • Validation Protocol Design: Create and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and cleaning procedures.
    • Process Optimization: Continuously improve manufacturing processes to enhance efficiency, reduce costs, and ensure product quality.
    • Risk Assessment: Conduct risk assessments and develop risk mitigation strategies for manufacturing processes.
    • Documentation: Maintain accurate and comprehensive validation documentation, including validation master plans, validation reports, and change control documents.
    • Regulatory Compliance: Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations and guidelines.
    • Collaboration: Collaborate with cross-functional teams, including Quality Assurance, Research and Development, and Production, to drive process improvements and resolve issues.
    • Troubleshooting: Investigate and troubleshoot process deviations and quality issues, implementing corrective and preventive actions (CAPA) as necessary.
    • Technology Transfer: Support technology transfer activities between development and manufacturing sites.
    • Training: Provide training to production and quality personnel on validation procedures and best practices.
    Requirements:
    • Bachelor's degree in chemical engineering, pharmaceutical sciences, or a related field.
    • Proven experience in pharmaceutical process validation, including equipment, process, and cleaning validation.
    • Strong knowledge of cGMP regulations and FDA guidelines.
    • Excellent problem-solving and analytical skills.
    • Proficiency in validation software and statistical analysis tools.
    • Effective communication and teamwork skills.
    • Detail-oriented with a strong commitment to quality and compliance.
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