CQV Engineer

Job Summary: The CQV Automation Engineer is responsible for executing and documenting automation commissioning, qualification, and testing activities within a GMP biotech or pharmaceutical manufacturing environment. This role supports automated systems, control equipment, and plant-wide automation networks while ensuring compliance with cGMP, GDP, and regulatory standards. The position requires close collaboration with cross-functional teams and on-site support during commissioning and operation

Job Title : CQV Location : Boston, MA General position summary: The Engineer is actively involved in Commissioning, Qualification, Validation, and Requalification activities for Cell and Gene Therapy facilities. The individual is responsible for executing qualification protocols facilities and collaborate with Global Engineering, Facilities Operations, GIS, QA and PMO throughout the life cycle of the project. Key Responsibilities: The responsibilities of this position may include, but are not

Job Description The Engineering Specialist is a key role within Our Company's Research Labs Pharmaceutical Sciences - Pharmaceutical Operations Engineering group (Pharm Ops Engineering), responsible for Commissioning, Qualification, and Validation (CQV) and broader engineering support across non-sterile operations, including formulation, filling, and packaging of Oral Solid Dosage and Inhalation products. The position leads CQV development and execution for new and modified processing equipmen

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati