Quality Engineer

Job Summary

Responsibilities

Responsible for ensuring that the integrated fill line facilities, equipment, and associated presses, as well as the quality processes that govern them, are affective, efficient, compliant, and remain in state of control. Responsible for evaluating for compliance and approval of Preventative Maintenance, Metrology, Validation, and Qualification activities for the integrated fill line 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 the integrated fill line equipment.

Job Responsibilities:

• Oversees engineering change controls (ECR) for critical equipment and controlled areas related to integrated fill lines 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.
• Troubleshoots problems related to equipment (water, HVAC, pest control, lyophilizers, vial washers, etc.) Analyzes data and implements both corrective and preventative actions to enhance processes.
• Analyzes data, supports root cause investigations, performs gap analysis and risk assessments, develops corrective or preventative actions, and implements procedural and physical changes to reduced 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.
• Addresses daily quality concerns and questions related to operating and environmental concerns. Implements and follows up on corrective actions.
• Provide in-process QA support to include document review and provide additional support for batch record review and critical processing steps, in order to meet production and release scheduling.
• Collaborate with cross-functional teams to establish and maintain quality control procedures and documentation.
• Assures standard operating procedures (SOPs) and batch records define the steps necessary to complete tasks. Writes, reviews, and updates documents as needed.
• Conducts process audits of all critical processes and equipment, as well as the quality processes that oversee them, and identifies gaps in compliance and opportunities for improvement.
• Provides training and support to manufacturing personnel on quality standards and procedures.
• Interacts with regulatory officials to convey the compliance level of the quality system during regulatory inspections.
• Prioritizes and efficiently completes tasks as assigned by the manager.
• All employees are responsible for ensuring the compliance to company documents, programs, and activities related to the healthy, safety, environment, energy, and quality management systems, as per their roles and responsibilities.

Job Requirements:

• B.S. degree in a technical science is required. Engineering, Chemistry, or Biology degree is highly preferred.
• 3 years of experience in a highly regulated industry required, preferably in the pharmaceutical industry.
• 3 years of experience in change control strongly preferred.
• Working knowledge of aseptic processing is strongly preferred.
• Working knowledge of cGMP practices including 21 CFR Part 210, 211, and art 11, Electronic Records, USP, ISO 13485 and 14644, and ISPE trends and guidelines.
• Experience with Trackwise, SAP, and eDMS preferred.
• Strong knowledge of relevant software, quality assurance methods, tools and quality manufacturing processes are strongly preferred.
• Familiar with statistical tools ad techniques for data analysis is strongly preferred.

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, and wellness 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.