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Manufacturing Engineer

Katalyst Healthcares and Life Sciences

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
Vacancy posted 4 days ago
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