AIT Quality Engineer: CQV & Validation Lead (Pharma)

NNE Inc.; Kalundborg; Remote; DKK 600,000 - 900,000; Full time

Job summary

Novo Nordisk Engineering (NNE) is seeking an experienced Quality Engineer for Automation and IT in Kalundborg, Denmark. You will lead validation activities, provide strategic guidance on GMP compliance, and drive quality across complex automation projects in pharma engineering.

You will work with multidisciplinary teams to ensure deliverables meet quality expectations, timelines, and customer requirements, with a focus on CQV, validation lifecycle management, and risk mitigation throughout the

Qualifications

• B.Sc., M.Sc., or equivalent degree in engineering, IT, life sciences, biotechnology, pharmaceutical sciences, or related field.
• Experience in CQV, validation, GMP, QA or project quality management in pharma, biotech or life sciences.
• Hands-on experience preparing and reviewing validation documentation (URS, FS/DS, SVP, IQ/OQ/PQ, risk assessments, test protocols).
• Knowledge of GMP, GAMP 5, ISPE guidance, data integrity, quality risk management, and validation lifecycle management.
• Ability to advise customers and project teams on validation strategy, compliance risks, and quality-related decisions.

Responsibilities

• Leading CQV and validation activities for automation, IT, computerized systems, and equipment interfaces in GMP-regulated projects.
• Developing and reviewing validation documentation (URS, FS/DS, SVP, IQ/OQ/PQ, risk assessments, test protocols, and summary reports).
• Executing qualification and testing activities while ensuring GMP compliance and customer expectations.
• Collaborating with customers, suppliers, and project teams throughout FAT, SAT, commissioning, validation and handover.
• Managing validation risks, deviations, compliance issues and mitigation actions across projects.

Skills

CQV

Validation

QA

Project quality management

Validation documentation

Education

B.Sc./M.Sc. or equivalent in engineering/IT/life sciences/pharma

Job description

Novo Nordisk Engineering (NNE) is seeking an experienced Quality Engineer for Automation and IT in Kalundborg, Denmark. You will lead validation activities, provide strategic guidance on GMP compliance, and drive quality across complex automation projects in pharma engineering.

You will work with multidisciplinary teams to ensure deliverables meet quality expectations, timelines, and customer requirements, with a focus on CQV, validation lifecycle management, and risk mitigation throughout the