What are the responsibilities and job description for the Validation Engineer position at United Pharma Technologies Inc?
Position: Validation Engineer
Location: Massachusetts
Position Overview
Our medical device client is seeking a mid-level Validation Engineer / Quality Engineer with a strong background in equipment and process validation to support the implementation of new additive manufacturing (3D printing) technologies at their Massachusetts facility.
This role will play a critical part in qualifying and validating newly installed titanium metal 3D printers and associated manufacturing processes. The ideal candidate will have experience in medical device manufacturing environments, hands-on validation expertise, and familiarity with additive manufacturing technologies. Experience with metal 3D printing is highly preferred; candidates with plastics-based 3D printing experience will also be considered.
Key Responsibilities
• Lead and execute equipment and process validation activities for new additive manufacturing systems.
• Develop, review, and approve validation documentation including:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation protocols and reports
• Support commissioning, qualification, and startup of new titanium 3D printing equipment.
• Collaborate with Manufacturing, Operations, Engineering, and Quality teams to ensure validated processes meet regulatory and quality requirements.
• Conduct risk assessments and validation impact assessments.
• Support process development and continuous improvement initiatives related to additive manufacturing.
• Investigate validation deviations and implement corrective actions as needed.
• Ensure compliance with ISO 13485 and applicable medical device regulations.
• Participate in equipment troubleshooting, process optimization, and manufacturing support activities.
• Assist with change control, nonconformance, CAPA, and quality system activities related to validated processes.