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Automation & IT CQV Senior Engineer

NNE (Novo Nordisk Engineering) · nne.com
ClaytonSenior
Apply on NNE (Novo Nordisk Engineering)’s site

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The job in short

CQV engineering for automation and IT systems in pharmaceutical manufacturing.

PLCCompliance

Details

Found
17 d ago · posted 2026-10-09
Location as listed
Clayton, NC, US
Role
Engineer (other)
Source
The company’s own careers site

Full description

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. 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.

Engineer (other) jobs in Clayton, North Carolina · Engineer (other) jobs in the United States · All NNE (Novo Nordisk Engineering) jobs

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