Manufacturing Engineer

Manufacturing Engineer

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