Senior Quality Engineer: Critical Systems & Compliance

RXinsider LTD.; Melrose Park (IL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holiday and personal /s

Health benefits: medical, dental, and视

Life insurance and disability

Wellness program

Job summary

Fresenius Kabi in the United States seeks a Primary Quality Owner for plant facilities, utilities, and critical systems. You will drive quality processes governing preventive maintenance, validations, metrology, and equipment qualifications to ensure regulatory compliance.

Collaborating with operations, R&D, quality, engineering, and maintenance, you will lead risk assessments, CAPA, investigations, and continuous improvement of facility monitoring and related systems to keep them in a state of

Responsibilities

• Delivers Quality ownership of the critical systems and any associated processes, as well as the quality processes that govern them.
• Drives engineering change control (ECR) for critical systems which include the timely pre-approval and post approval of change controls.
• Oversees all aspects for unplanned repairs conducted within the facility for Maintenance Incident (MI).
• Provides support to the plant during manufacturing as well as during maintenance facility shutdown activities both of which include off shift coverage (holidays/ weekends).
• Provides technical quality engineering oversight for software validations, equipment qualifications, and facility commissioning prior to validation.Reviews, and approves validations documentation for critical systems.
• Troubleshoots problems related to critical systems (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc).
• Analyzes data and implements both corrective and preventative actions (CAPA) to enhance processes.
• Works with Engineering & Maintenance to identify possible trends in Facility Monitoring System (FMS) alarms and review impact.
• Leads, manages, or participates in technical quality engineering projects and teams to implement improvements to the facilities and equipment quality systems infrastructure to meet regulatory requirements. Proactively taking ownership of quality processes and implementing solutions in support of continuous improvement.
• Leads and/or coordinates investigations (Events) related to critical systems and equipment.
• Analyzes data, conducts root cause investigations, performs gap analyses and risk assessments, develops corrective or preventive actions, and implements procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Reviews and approves technical quality engineering documentation such as Event, OOT, OOS, and complaint investigations, ensuring adequate root cause analysis as well as identification and implementation of corrective and preventative actions (CAPA).
• Reviews and approves technical quality engineering documentation such as master batch records, specifications, SOPs, Requalification studies, and other associated Validations driven documentation.
• Analyzes system and document changes for appropriateness and ensures adequate impact analysis.
• Reviews and approves weekly system releases for ECR, MI, and FMS.
• Interacts with the regulatory officials to convey the compliance level of the critical systems during regulatory inspections.
• Provides training to appropriate personnel related to critical quality systems.
• Maintain critical system quality attributes metrics to drive the process of continuous improvement.
• Responsible for any additional tasks as assigned by the Manager.

Job description

Fresenius Kabi in the United States seeks a Primary Quality Owner for plant facilities, utilities, and critical systems. You will drive quality processes governing preventive maintenance, validations, metrology, and equipment qualifications to ensure regulatory compliance.

Collaborating with operations, R&D, quality, engineering, and maintenance, you will lead risk assessments, CAPA, investigations, and continuous improvement of facility monitoring and related systems to keep them in a state of