Quality Engineer

Job Summary

Responsible for ensuring that all plant facilities and equipment (critical systems) and associated processes, as well as the quality processes that govern them, are effective, efficient, compliant and remain in a state of control. Responsible for evaluating for compliance and approval of Preventative Maintenance, Metrology, Validation and Qualification activities for all critical systems. Work in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance to solve problems and provide support on compliance issues and corporate quality policy requirements relating to critical systems.

Salary Range : $60,966-$85,694 annually

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

Responsibilities

• Responsible for reviewing weekly system releases.
• Oversees engineering change controls (ECR) for critical equipment and controlled areas which include preapproval and post approval of change controls.
• Provides support to the plant during operational run times as well as during maintenance shutdown activities both of which include off shift coverage.
• Provides quality oversight for software validation, equipment qualification, and facility commissioning and validation. Drafts, and reviews validation documentation for critical systems and equipment.
• Troubleshoots problems related to critical systems and equipment (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc). Analyzes data and implements both corrective and preventative actions to enhance processes.
• 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.
• Proactively takes ownership of quality processes and implements solutions in support of continuous improvement.
• Works with Engineering & Maintenance to identify possible trends in FMS and review impact.
• Develops, red-lines, reviews, and / or implements quality documents related to critical systems, processes and equipment.
• Conducts internal audits of all critical systems, processes and equipment, as well as the quality processes that oversee them, and identifies gaps in compliance and opportunities for improvement.

Requirements

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.

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.