Compliance Engineer

Within the Reliability & Support team, part of the wider Engineering & Maintenance organisation, you will act as the primary point of contact for quality and compliance-related activities. This role is ideally suited for someone who combines strong technical expertise with a solid understanding of quality systems and GMP requirements.

Rather than being a purely QA-focused position, you will operate at the intersection of Quality, Engineering, Maintenance and Qualification, ensuring compliance while supporting operational and technical excellence. The role requires a proactive, independent professional with strong communication and stakeholder management skills.

Responsibilities

• Own and manage quality-related actions, records and workflows within the Quality Management System (Veeva).
• Lead and coordinate root cause investigations associated with deviations impacting equipment, systems and maintenance processes.
• Drive the preparation and execution of change controls in close collaboration with stakeholders from Engineering, Production, Quality and Qualification.
• Support the development and follow-up of effective CAPA plans, ensuring timely implementation and closure.
• Ensure periodic reviews and compliance of departmental procedures and documentation.
• Provide day-to-day compliance support and guidance to Engineering and Maintenance teams.
• Contribute to continuous improvement initiatives aimed at strengthening quality and compliance across the department.

Profile

• Bachelor's or Master's degree in a scientific or technical discipline.
• Strong qualification background combined with a clear technical affinity, which is essential for this position.
• Approximately 5 to 10 years of relevant experience within a GMP-regulated pharmaceutical environment.
• Excellent communication skills and the ability to work autonomously in a complex, multidisciplinary setting.
• Good knowledge of pharmaceutical regulations and guidelines, including EudraLex, Annex 1, ICH and relevant ISPE guidance.
• Experience working with Quality Management Systems in a compliance-driven role is highly valued.
• Pragmatic, solution-oriented and confident in making decisions while balancing quality and operational needs.
• A hands-on mindset with the ability to build strong relationships across multiple departments.