Guerbet · 1 day ago
Compliance Specialist
Raleigh, NC
Full-time
Onsite
Mid Level
3+ years expGuerbet is seeking a Compliance Specialist – Engineering responsible for ensuring compliance with internal policies and regulatory requirements in engineering and maintenance operations. The role involves managing CAPAs, Change Controls, and maintaining documentation accuracy while collaborating with various teams to support audit readiness.
Health CareMedicalPharmaceutical
Hiring Manager
Kris Adams
Responsibilities
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
Qualification
Required
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 analytical, organizational, and communication skills
Strong attention to detail and ability to manage multiple priorities
Proficient in Microsoft Office and Quality Management Systems (QMS)
Company
Guerbet
Guebert is a pharmaceutical company based in France and is mainly focused on research.
1001-5000 employees
H1B Sponsorship
Guerbet has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$0.96M2022-09-26Post Ipo Equity· $0.96M
1999-04-01IPO
Leadership Team
François Convenant
Global Vice President Commercial, Interventional Imaging
Recent News
2025-12-02
Company data provided by crunchbase