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Manufacturing Engineer

Katalyst Healthcares & Life Sciences

  • Marietta, GA
  • 30+ days ago

    Highlights

    Required Skills & Competencies: Bachelor's degree in engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years' experience. Key Responsibilities: Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes.

    Numbers & Facts

    LocationMarietta, GA

    Description

    Job Description:
    Role Summary:
    • The Manufacturing Engineer will support equipment and process validation activities (IQ/OQ/PQ) for a medical device production facility.
    • The role involves ensuring that manufacturing systems, equipment, and processes meet regulatory, quality, and performance standards while supporting production readiness and compliance.

    Key Responsibilities:
    • Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes
    • Develop, review, and execute validation protocols and reports in compliance with FDA and regulatory standards.
    • Coordinate with cross-functional teams (Quality, R&D, Production, and Validation teams) for successful validation execution.
    • Support equipment installation, commissioning, and troubleshooting activities
    • Ensure adherence to Good Manufacturing Practices (GMP) and quality systems
    • Perform risk assessments (FMEA) and contribute to process improvements
    • Maintain accurate documentation, traceability, and validation records
    • Participate in process optimization and continuous improvement initiatives
    • Support audits, inspections, and regulatory submissions as needed

    Required Skills & Competencies:
    • Bachelor's degree in engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years' experience
    • Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle
    • Knowledge of medical device regulations (FDA, ISO 13485)
    • Experience in manufacturing processes, equipment qualification, and process validation
    • Familiarity with GMP, CAPA, and change control processes
    • Ability to read and interpret engineering drawings, P&IDs, and technical specifications
    • Strong problem-solving and analytical skills
    • Excellent communication and documentation skills

    Preferred Qualifications:
    • Experience in medical device or regulated manufacturing environment
    • Exposure to cleanroom manufacturing environments
    • Familiarity with statistical tools and validation software
    • Experience supporting automation systems or complex manufacturing equipment

    Work Environment:
    • Full-time onsite role in a regulated medical manufacturing facility
    • Requires collaboration with cross-functional teams and shop-floor presence

    Key Deliverables:
    • Approved IQ/OQ/PQ protocols and reports
    • Equipment qualification and validation documentation
    • Compliance with regulatory and quality standards
    • Timely execution of validation and production readiness activities

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