Job Summary

Responsibilities

• 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. ​

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.