Sr Quality Engineer, Critical Systems

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

Job Summary

Primary Quality Owner of all plant facilities, utilities, and equipment (critical systems) and associated processes, as well as the quality processes that govern them. Responsible for developing, evaluating, and ensuring compliance and efficient approval of Preventative Maintenance, Metrology, Validations, Engineering documentation, and Qualification activities for all critical systems. Drives the execution and/or coordinates Risk and Gap Assessment analysis to ensure that the critical systems are in a state of control. Proactively leads facilities, utilities, and equipment quality systems enhancement projects to decrease the likelihood of action resulting from a regulatory inspection. Works in partnership with manufacturing operations, research and development, quality unit, engineering, maintenance, and validations to solve problems and provide expertise on compliance issues and corporate quality policy requirements relating to critical systems.

Responsibilities

1) Delivers Quality ownership of the critical systems and any associated processes, as well as the quality processes that govern them.

2) Drives engineering change control (ECR) for critical systems which include the timely pre-approval and post approval of change controls.

3) Oversees all aspects for unplanned repairs conducted within the facility for Maintenance Incident (MI).

4) Provides support to the plant during manufacturing as well as during maintenance facility shutdown activities both of which include off shift coverage (holidays/ weekends).

5) Provides technical quality engineering oversight for software validations, equipment qualifications, and facility commissioning prior to validation.Reviews, and approves validations documentation for critical systems.

6) Troubleshoots problems related to critical systems (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc).

7) Analyzes data and implements both corrective and preventative actions (CAPA) to enhance processes.

8) Works with Engineering & Maintenance to identify possible trends in Facility Monitoring System (FMS) alarms and review impact.

9) 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.

10) Leads and/or coordinates investigations (Events) related to critical systems and equipment.

11) 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.

12) 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).

13) Reviews and approves technical quality engineering documentation such as master batch records, specifications, SOPs, Requalification studies, and other associated Validations driven documentation.

14) Analyzes system and document changes for appropriateness and ensures adequate impact analysis.

15) Reviews and approves weekly system releases for ECR, MI, and FMS.

16) Interacts with the regulatory officials to convey the compliance level of the critical systems during regulatory inspections.

17) Provides training to appropriate personnel related to critical quality systems.

18) Maintain critical system quality attributes metrics to drive the process of continuous improvement.

19) Responsible for any additional tasks as assigned by the Manager.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Salary range from $90,000 - $120,000

The position is eligible to participate in a bonus plan with a target of 6% of the base pay.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.