Senior AIT Quality Engineer (Pharmaceutical, Kalundborg)

Job summary

The role involves leading quality and validation activities within complex Automation and IT projects in the pharmaceutical sector. The Senior AIT Quality Engineer will work closely with multidisciplinary teams to ensure compliance with quality standards and project requirements throughout the project lifecycle.

Qualifications

• Minimum of 5 years of experience in CQV, validation, quality, GMP, or project quality management in pharmaceutical, biotechnology, or life sciences.
• Bachelor's or Master's degree in engineering, IT, life sciences, biotechnology, pharmaceutical sciences, or a related field.
• Familiarity with validation lifecycle documentation such as validation plans, risk assessments, and test protocols.
• Knowledge of quality and regulatory expectations including GMP, GAMP 5, and quality risk management.

Responsibilities

• Lead and coordinate CQV and validation activities for automation and IT projects in GMP-regulated environments.
• Develop and review validation lifecycle documentation and ensure alignment with industry standards and customer expectations.
• Execute qualification and test activities, troubleshooting compliance challenges as needed.
• Collaborate with various stakeholders during design reviews, validation, and handover activities.
• Identify and escalate project risks and compliance concerns, presenting updates to stakeholders.

Skills

• Strong communication skills with the ability to convey complex topics clearly.
• Ability to work independently while maintaining close connections with team members and stakeholders.
• Strong problem-solving skills and a proactive approach to project management.

Education

• B.Sc., M.Sc., or similar degree in a relevant field.

Tools

• Experience with validation lifecycle management tools and methodologies.