Quality Engineering and Validation

Position: Quality Engineering and Validation

Location: Boston, MA

Duration: Long Term

Job Overview

We are seeking a Quality Engineering and Validation professional to provide quality oversight and GMP compliance support for clinical and commercial drug product manufacturing operations. The ideal candidate will have experience supporting GMP manufacturing, validation activities, investigations, and quality systems within a regulated life sciences environment.

Key Responsibilities

• Provide QA oversight and support for GMP manufacturing operations and capital projects.
• Support validation activities, change controls, risk assessments, GMP investigations, and CAPAs.
• Identify quality risks and ensure compliance with GMP processes and quality systems.
• Review calibration records, preventive maintenance, work orders, and laboratory instrument qualification activities.
• Review and approve equipment, facility, and utility trending programs.
• Support environmental monitoring, routine testing, and facility control programs.
• Collaborate with cross-functional teams to ensure quality compliance and timely issue resolution.

Required Qualifications

• Master's degree with 3 5 years of relevant experience, or Bachelor's degree in Engineering, Scientific, or related field with 8+ years of relevant experience.
• Experience providing QA support for GMP manufacturing operations and validation activities.
• Experience with aseptic processing, investigations, root cause analysis, and CAPA.
• Knowledge of GMP regulations, quality systems, and risk-based decision making.
• Experience with Veeva, Nuvolo, ViewLinc, or similar quality management systems.
• Strong communication, collaboration, problem-solving, and organizational skills.