Group Leader, Production

5 days ago

Melrose Park, United States Fresenius Kabi Full time

Job Summary

The Production Group Leader will be responsible for all daily operations of functional department without direct supervision on the shift. Responsible for training all employees on that shift, allocating resources, scheduling shift activity and insuring cGMP compliance in operation. This cross-functional role is also responsible for assembling, operating, and monitoring state-of-the-art, aseptic equipment following applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of and practice good aseptic techniques to minimize the potential for product contamination as well as understand advanced computerized systems through HMI.

**Responsibilities**:

- Perform expert level machine operation, set-up and troubleshooting of all state-of-the-art equipment in their area (may include Vial Washer, Depyrogenation Tunnel, Filling Machine, Isolator, Stopper Loading Systems, Capping Machine, Glove Tester, Automatic Loading & Unloading System (ALUS), Lyophilizers, Parts Washers, Component Sterilizers, Stopper Cans, Filter Integrity Tester, Vaporized Hydrogen Peroxide Transfer Hatch) to meet process parameters.
- Expert understanding of alarm consequences and resolutions.
- Technical comprehension of mechanical, electrical and controls functions for equipment in their area to the extent of an expert level.
- Adept at problem-solving. Specifically, to identify problems, develop solutions, and execution of remedy. Able to form refined problem statements to escalate to Management if necessary.
- Load Parts Washer, Component Sterilizer, Vial Washer, Filling Machine and Capping Machine with raw materials and format parts.
- Practice and understand aseptic manufacturing principles.
- Maintain gown qualification if required by their area.
- Perform microbiological monitoring within the Filling Machine, ALUS, and Capping Machine.
- Interface with other departments including MQA, Maintenance, Metrology, Engineering, Validation, Tech Transfer and Microbiology, with tasks on the equipment in their area.
- Maintain format parts carts inventory and identify worn/damaged parts to escalate to Supervision.
- Prepare work orders and change controls as needed to keep equipment in proper working condition.
- Coordinate all aspects of department operations to include schedule changes, qualify issues, and distribution of resources and break schedules.
- Ensure all employees are following safety, cGMP and department policies and procedures. Able to communicate issues or non-compliance to Supervisor when necessary.
- Effectively communicate with Supervisor on equipment schedule/component status, or safety concerns, personnel performance, and short-term goals & priorities.
- Manage employee training questions, conflicts, and concerns. Consult Supervisor when necessary.
- Review all batch records for accuracy and completeness.
- Qualified Trainer and creator of training plan for the equipment in their area and capable of effectively communicating.
- Train employees on departmental procedures, set-up/operation of equipment, and troubleshooting techniques.
- Evaluate employee performance and assist in preparing performance reviews. Provide appropriate coaching and feedback to employees to develop high performing teams.
- Clean and sanitize equipment and Production areas per SOP.
- Transfer raw materials, operating supplies, and finished product in and out of the manufacturing areas.
- Multi-task and learn multiple manufacturing areas 25) Train and comply with current SOPs and GMPs.
- Document work accurately and timely.
- Understand the process flow and step by step requirements for manufacturing.
- Work in a time efficient manner while maintaining adherence to all applicable SOPs.
- Concise communication with co-workers and managers to promote a teamwork atmosphere.
- Perform other duties as directed.
- All employees are responsible for ensuring compliance with company documents, programs, and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems as per your roles and responsibilities._

Job Requirements
- High School Diploma / GED
- Worked as a Production Technician III at Fresenius Kabi for a minimum of one year or relevant prior experience.
- Expert mechanical and HMI aptitude.
- Technical comprehension of mechanical functions and controls of automated equipment.

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 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.

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