JobMesh

Senior Validation Engineer

Millstone Medical · Fall River, Massachusetts, US

Key Responsibilities: - Equipment and Process Validation: - Document and execute Installation Qualification (IQ), Operational Qualification (OQ), and Perform...

Job description

Key Responsibilities: Equipment and Process Validation: - Document and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various manufacturing equipment and end-of-line processes. - Ensure that all validations are conducted in accordance with Good Manufacturing Practices (GMPs) and meet customer and regulatory requirements. Manufacturing Work Instructions: - Develop, maintain, and update manufacturing work instructions to ensure that validated processes are accurately followed in production. - Collaborate with operations and quality teams to ensure work instructions are clear, concise, and effective. Customer Interface: - Serve as a technical liaison between the company and customers, addressing technical issues, project timelines, and validation support. - Communicate effectively with customers to manage expectations and ensure alignment on validation activities. Cross-Functional Team Participation: - Actively participate in cross-functional teams to investigate and determine the root cause of issues and develop corrective actions. - Collaborate with Quality, Manufacturing, and R&D teams to support continuous...