Process Quality Engineer II

Join to apply for the In-Process Quality Engineer II role at Guerbet

At Guerbet, we build lasting relationships so that people can live better. We are a global leader in medical imaging, offering pharmaceuticals, medical devices, digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for 100 years, we continuously innovate to improve diagnosis, prognosis and quality of life of patients.

• Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
• Perform required QA inspections; sample defect detection.
• Participate in internal audits as requested.
• Provide primary daily support to the operations/packaging area, including packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real‑time review.
• Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, assessing impact, containment, bracketing, scope identification, and directing immediate actions.
• Assist personnel in generating operations/packaging area related exceptions.
• Support minor exceptions and phase II manufacturing investigations.
• Attend daily operations staff communication meetings.
• Team member of Facilities meetings regarding operations preventive maintenance/calibration/work order status and scheduling.
• Team member during area shutdown or maintenance projects as needed, assisting in punch list generation & verification and area inspections pre/post activity.
• Perform weekly walkthroughs of the operations/packaging area and communicate observations.
• Support the QA label release functions as needed.

• Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
• Perform QA inspections; sample defect detection.
• Participate in internal audits.
• Provide daily support to operations/packaging area, including line clearance, material segregation/containment, low product fill response, rework reconciliations/accountabilities, real‑time documentation review.
• Respond to exceptions within operations/packaging areas, assessing impact, containment, bracketing, scope identification, and directing immediate actions.
• Assist in generating operations/packaging area exceptions.
• Support minor exceptions and phase II investigations.
• Attend daily operations staff communication meetings.
• Team member of Facilities meetings concerning operations preventive maintenance/calibration/work order status and scheduling.
• Assistant during area shutdown or maintenance projects as needed, generating punch lists & verification and area inspections pre/post activity.
• Perform weekly walkthroughs of the operations/packaging area and communicate observations.
• Support QA label release functions as needed.

• Work safely in accordance with regulations, standards, and procedures and eliminate unreasonable risk to health and the environment.
• Notify management of unsafe conditions or practices, unlawful activities, and activities that present unreasonable health and/or environmental risk.
• Report all safety and/or environmental incidents to management immediately.
• Other duties as assigned with or without accommodation.

• BS/BA degree in Science/Business preferred.
• Bachelor’s degree in life sciences preferred.
• Minimum 6 years experience in a pharmaceutical QA/Mfg environment.
• ASQ inspection certification.
• Previous experience with statistical sampling plans.
• Previous experience in investigation root cause analysis and/or writing.
• Ability to work in a fast‑paced environment.
• Ability to adjust work schedule to meet operations and customer demand.
• Must be able to wear appropriate personal protective equipment to ensure safe execution of job responsibilities.

• Skilled competency with computers, MS Office software required.
• Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred.