Automation & IT CQV Senior Engineer

About the job

As an Automation IT CQV Senior Engineer, you are responsible for planning, executing, and delivering commissioning, qualification, and validation (CQV) activities across pharmaceutical manufacturing systems and projects. You will work independently while coordinating with engineering, Automation IT, Quality, project management, suppliers, customers, and other project stakeholders. Depending on project scope, you may also serve as a technical SME or lead defined project workstreams.

CQV Execution Plan, execute, and document Design Review/Qualification, IQ, OQ, PQ, and Process Validation activities based on project scope. Author and review validation plans, specifications, risk assessments, traceability matrices, protocols, reports, and other lifecycle documentation. Support commissioning and qualification readiness, including FAT activities and coordination across engineering, Automation IT, Quality, suppliers, and operations.

Investigate deviations and engineering changes, support Change Controls, and assess validation impacts. Create, revise, route, and maintain compliant electronic validation records in approved validation and quality systems. Systems Technical Expertise Support CQV activities across pharmaceutical manufacturing equipment, including aseptic formulation and filling, vision inspection, medical-device assembly, and packaging.

Apply CQV expertise to automation and manufacturing IT systems such as DeltaV, Syncade, SCADA, PLC, and PAS-X. Support laboratories, facilities, and utilities, including instrumentation, monitoring and calibration, BMS, HVAC, refrigeration, and GMP utility systems. Support system modernization, lifecycle replacement, and electronic validation execution.

Project, Client Team Support Coordinate CQV deliverables and communicate project status, risks, constraints, and escalations. Collaborate across technical disciplines and with customers, suppliers, Quality, and project stakeholders. Serve as a technical SME or lead defined CQV workstreams based on project needs.

Review work and coach junior colleagues while promoting quality, compliance, and best practices. Contribute technical expertise to continuous improvement and development of customer solutions. The Senior Automation IT profile specifically supports independent delivery, reviewing and coaching junior colleagues, SME-level knowledge, customer engagement, and the ability to assume Project SME or Project Lead responsibilities.