Compliance Specialist - Engineering

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We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

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Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

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The Compliance Specialist – Engineering is responsible for ensuring that all engineering, maintenance, and facilities operations remain in compliance with internal policies, Good Manufacturing Practices (GMP), and regulatory requirements. This role manages and oversees the generation, revision, and closure of CAPAs, Change Controls, and Exceptions within the Engineering and Maintenance Department. The position also maintains and updates engineering and maintenance procedures, job plans, and work instructions, ensures documentation accuracy, and develops compliance metrics to support continuous improvement and audit readiness.

• Manage and coordinate all CAPA, Change Control, and Exception records related to Engineering and Maintenance activities to ensure timely completion and compliance with GMP requirements.
• Support deviation investigations and ensure proper root cause analysis and corrective/preventive actions are documented and implemented.
• Review, generate, and update maintenance job plans, SOPs, and work instructions in alignment with current GMP and engineering best practices.
• Maintain Engineering document control related to equipment, maintenance, utilities, and facilities.
• Collaborate with Engineering, Maintenance, Quality, and Validation teams to ensure audit readiness and regulatory inspection support.
• Develop and distribute Engineering and Maintenance Compliance Metrics, including CAPA aging, Change Control cycle time, documentation accuracy, and PM completion rates.
• Track compliance-related action items, monitor progress, and report status to management.
• Conduct periodic compliance reviews of maintenance and engineering documentation.
• Support training initiatives for engineering personnel to reinforce compliance awareness and adherence to SOPs and GMP practices.
• Participate in continuous improvement projects to enhance compliance and operational efficiency.
• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and-or environmental incidents to management immediately unreasonable health and/or environmental risk. Report all safety and-or environmental incidents to management immediately.
• Maintain compliance within Engineering and Maintenance systems (e.g., job plans, PM records, work orders).
• Support technical investigations and maintenance documentation updates.
• Collaborate with Quality, Validation, Production, and EHS for compliance initiatives.
• Participate in corporate or site-wide audits, CAPA reviews, and training sessions as required.
• Other duties as assigned with or without accommodation

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field required.
• Minimum of 3–5 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment.
• Strong understanding of GMP, FDA, and ISO regulations.
• Experience managing CAPA, Change Control, and Deviation systems.
• Familiarity with maintenance and calibration systems (e.g., CMMS such as Maximo).
• Excellent…