Raleigh, US
At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
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.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
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.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube
WHAT WE ARE LOOKING FOR
The Asset Management Manager is responsible for leading the strategic management of the site’s assets to ensure reliability, compliance, and efficiency across all manufacturing and utility systems. The position also leads the Process Engineering team, responsible for developing, improving, and sustaining preventive maintenance programs and reliability initiatives.
In addition, the Asset Management Manager is accountable for continuous improvement projects focused on equipment performance, cost reduction, and process optimization, as well as ensuring compliance of all engineering and maintenance programs with internal SOPs, GMP regulations, and corporate standards. This includes leading and managing CAPAs, change controls, deviations/exceptions, SOPs, and work instruction revisions within the Engineering, Maintenance, and Facilities scope.
YOUR ROLE
- Manage and develop the Process Engineering team, ensuring robust preventive maintenance programs, spare parts strategies, and continuous improvement initiatives.
- Drive continuous improvement projects aimed at enhancing equipment reliability, maintenance efficiency, and cost-effectiveness.
- Ensure compliance with GMP, FDA, and corporate standards in all engineering, maintenance, and facilities programs.
- Lead and coordinate CAPA, change control, deviations, and exception investigations related to engineering, maintenance, and facilities operations.
- Develop, review, and approve SOPs, work instructions, and technical documentation related to maintenance and asset management.
- Partner with Quality, Production, and Validation to ensure alignment on system ownership, documentation, and improvement plans.
- Develop and maintain performance metrics and dashboards for asset reliability, work order completion, and compliance performance.
- Provide leadership, coaching, and technical support to engineers, compliance specialists, and maintenance teams.
- Support capital and expense planning through asset condition assessments and reliability data analysis.
- 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.
- Lead 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. Lead the site’s Asset Management Program, ensuring assets are managed through their full lifecycle with a focus on reliability, compliance, and performance.
- Manage the CMMS, including data structure, asset hierarchy, PM plans, work order management, and KPI tracking.
Department Specific/Non-Essential Functions:
- 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.
- 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.
- Participate in cross-functional investigations and technical assessments.
- Other duties as assigned with or without accommodation
YOUR BACKGROUND
- Bachelor’s Degree in Engineering (Mechanical, Electrical, Industrial, or related field) required.
- Master’s Degree preferred.
- Minimum of 8–10 years of experience in maintenance, reliability, or engineering management in a pharmaceutical or regulated manufacturing environment.
- Experience with CMMS administration (Maximo preferred) and asset performance management systems.
- Proven experience in leading CAPA, change control, and compliance documentation processes.
- Demonstrated experience leading technical teams and driving process improvements.
- Strong understanding of GMP, FDA, and ISO regulations.
- Familiarity with maintenance and calibration systems (e.g., CMMS such as Maximo).
- Excellent analytical, organizational, and communication skills.
- Strong attention to detail and ability to manage multiple priorities.
- Proficient in Microsoft Office and Quality Management Systems (QMS).
Physical Requirements
- Ability to sit, stand, and walk for extended periods in an office and manufacturing environment.
- Occasionally required to access mechanical spaces, utility rooms, or production areas (requiring PPE).
- Must be able to lift up to 25 lbs occasionally.
- Visual acuity to review documentation and electronic data.
Cognitive Requirements
- Strong analytical, problem-solving, and decision-making skills.
- Ability to interpret and apply complex regulations and quality standards.
- Capacity to manage multiple priorities and deadlines under minimal supervision.
- Effective written and verbal communication and critical thinking abilities.
- Excellent organizational, planning, and decision-making skills.
- Strong leadership and interpersonal communication skills.
- Capability to interpret engineering drawings, maintenance procedures, and regulatory requirements.
- Attention to detail and commitment to data integrity (ALCOA principles).
Working Conditions
- Normal office conditions but will spend significant time on the production floor and facilities/utilities area.
- On-site role in manufacturing plant environment
- May require occasional off-shift or weekend work to support manufacturing operations and projects
- Exposure to typical pharmaceutical production conditions, including cleanrooms, mechanical spaces, and utilities.
- Standard business hours with flexibility to support off-hour or weekend compliance activities as required.
- May be required to participate in audits or emergency responses outside of regular working hours.