- 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. Drafts, executes and approves validation documentation for critical equipment.
- 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, 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.
- Addresses daily quality concerns and questions related to operating and environmental concerns. Implements and follows up on corrective actions.
- Provides additional support for batch record review and critical processing steps, in order to meet production and release scheduling.
- Assures standard operating procedures (SOPs) and batch records define the steps necessary to complete tasks. Writes, reviews, and updates documents as needed.
- Conducts internal 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 to appropriate personnel related to facilities and equipment quality system.
- Interacts with regulatory officials to convey the compliance level of the quality system during regulatory inspections.
- Prioritizes and efficiently completes tasks with minimal supervision and consistently delivers on commitments by date requested.
- Responsible for any additional tasks as assigned by the Manager.
- B.S. degree in a technical science is required. Engineering degree is highly preferred.
- 3 years' experience in a highly regulated industry required.
- 3 years' experience in the pharmaceutical industry highly preferred.
- 3 years' experience in change control preferred.
- Working knowledge of aseptic processing is highly preferred.
- Working knowledge of cGMP practices to include 21 CFR Part 210, 211 and Part 11, electronic records, USP, ISO 13485 and 14644 and ISPE trends and guidelines.
- CQE or CSSGB is a plus
- Experience with Trackwise and Documentum preferred.
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quality engineer - Melrose Park, United States - Fresenius Kabi AG
Description
Job Summary*This is a 3rd shift role in Melrose Park*
Responsible for ensuring that the integrated fill line facilities, equipment 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 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.
Responsibilities
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness 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.
