Manufacturing Engineer
Katalyst Healthcares and Life Sciences
Job Description:
Role Summary:
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.
- 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
- 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
- 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
- Full-time onsite role in a regulated medical manufacturing facility
- Requires collaboration with cross-functional teams and shop-floor presence
- 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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