Pharma AIT Quality Engineer — CQV & Validation

NNE; København; On-site; DKK 700,000 - 900,000; Full time

Job summary

NNE is seeking an AIT Quality Engineer to join the AIT Project Quality Management team in Kalundborg. You will plan, drive, and deliver validation and quality activities within complex Automation and IT projects in pharma engineering.

You will work as part of multidisciplinary project teams, advising on validation strategy, GMP compliance, quality risk management, and project quality execution from initiation to handover.

Qualifications

• B.Sc., M.Sc., or equivalent degree in engineering, IT, life sciences, biotechnology, pharmaceutical sciences, or a related field.
• Experience within CQV, validation, GMP, QA, or project quality management in the pharmaceutical, biotech, or life science industry.
• Hands-on experience preparing and reviewing validation documentation, including URS, FS/DS, SVP, IQ/OQ/PQ, risk assessments, and 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, including URS, FS/DS, SVP, IQ/OQ/PQ, risk assessments, test protocols, and summary reports.
• Executing qualification and testing activities while ensuring compliance with GMP requirements, industry standards, 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

GMP

QA

Project quality management

Education

B.Sc./M.Sc. in engineering or life sciences

Job description

NNE is seeking an AIT Quality Engineer to join the AIT Project Quality Management team in Kalundborg. You will plan, drive, and deliver validation and quality activities within complex Automation and IT projects in pharma engineering.

You will work as part of multidisciplinary project teams, advising on validation strategy, GMP compliance, quality risk management, and project quality execution from initiation to handover.