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Process Validation Engineer

Katalyst Healthcares & Life Sciences

  • Harrisburg, PA
  • 23 days ago

    Highlights

    The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance. Job Description: We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment.

    Numbers & Facts

    LocationHarrisburg, PA

    Description

    Job Description:
    • We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance.
    Responsibilities:
    • Develop and execute process validation strategies for new and existing sterile manufacturing processes.
    • Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
    • Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
    • Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
    • Perform process revalidation activities and maintain validated manufacturing processes.
    • Support smoke studies and qualification activities for automated visual inspection systems.
    • Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
    • Prepare and review validation protocols, reports, risk assessments, and technical documentation.
    • Ensure compliance with cGMP, FDA regulations, and industry best practices.
    • Provide technical support for investigations, process improvements, and continuous improvement initiatives.
    Requirements:
    • Bachelor's degree in engineering, Life Sciences, or a related discipline.
    • Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
    • Hands-on experience with Technology Transfer and PPQ execution.
    • Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
    • Experience supporting smoke studies and qualification activities.
    • Excellent technical writing, communication, and cross-functional collaboration skills.
    • Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.

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