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.

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.

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.