- Provides oversight to ensure a safe, effective and efficient operation of manufacturing equipment, ensuring conformance to all quality standards, applicable Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (cGMPs) and compliance with all company requirements.
- Must be a qualified trainer (QT), must understand advanced automated systems, and be knowledgeable of good cleanroom technique to minimize potential for product contamination.
- Thorough understanding of equipment operation, batch record requirements, and reviews all documentation during production and batch reconciliation.
- Supervises the day-to-day of the operators and group leads while promoting teamwork. This includes on-time training, on-boarding of new employees, performing employee corrective actions as needed, and develops an execution plan for training and follow-ups to enhance staff development. This will occur via regular evaluations of the performance of their operations personnel.
- Assumes responsibility for the equipment condition, and facility condition and that the area remains in an “audit ready” state via the general upkeep of the area.
- Responsible for the cleaning program and the maintenance preventive work of the equipment.
- Coordinates the execution of the production schedule and equipment changeovers based on the schedule. This includes the monitoring the adherence to the production schedules, production metrics, and activities to ensure departmental performance objectives and budgets are met.
- Oversees the production processes on their assigned shift, across multiple manufacturing lines/areas while working on the production floor to coordinate all relevant production activities.
- Ensures that the documentation, for the area of responsibility, is accurate and in alignment to the Good Documentation Practice standards via the implementation of a peer to peer real-time review process to ensure the quick close out of batch records prior to supervisor review. Batch records must be reviewed in a timely manner to ensure timely release of the products.
- Able to identify and aid in the completion of thorough deviations in a timely manner while performing detailed root cause analysis and implementing corrective and preventative actions. This may also include updating and/or enhancing departmental SOPs and/or Batch Records and writing to support investigation reports and mitigation plans as required.
- Establishes effective communication methods to provide continuity of information across all operations and shifts
- Adheres to SOP’s, Company Policies, cGMP’s, and Safety Requirements.Interacts with other management staff and support groups to maintain compliance with procedures, standards, policies and cGMP’s.
- Recommends and implements process improvements by being a Subject Matter Expert (SME) of their area of responsibility and by empowering the personnel to offer solutions.
- Contributes to development of annual departmental operating budget.
- Provides a daily update on the performance of the shift.
- Able to perform risk-based decisions. Adept at problem solving. Specifically, to identify problem, developing solution, and execute corrections while adhering to all applicable SOPs.
- Empowers assigned personnel to engage in defining and recommending continuous process improvements.
- Monitors and controls production schedules and activities to ensure departmental performance objectives and budgetsare met.
- Assume other duties and responsibilities as assigned.
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.
Skills Required
- Qualified Trainer (QT)
- Thorough understanding of cGMP and Good Documentation Practices
- Knowledgeable in cleanroom technique to minimize contamination
- Understanding of advanced automated manufacturing systems
- Thorough understanding of equipment operation and batch record requirements
- Experience supervising production personnel including training and corrective actions
- Ability to perform root cause analysis and implement corrective and preventative actions (CAPA)
- Familiarity with production scheduling, equipment changeovers, and meeting production metrics
- Responsible for cleaning program and preventive maintenance oversight
- Strong problem-solving and risk-based decision-making skills
What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Fresenius Kabi Community Guidelines and User Information: https://www.fresenius-kabi.com/social-media-terms-conditions Imprint: https://www.fresenius-kabi.com/imprint







