Job Description

The Production Technician I position is responsible for the operation of high speed equipment used in the production and packaging of VITEK 2 cards in a cGMP compliant manner. The position may perform or assist in the setup, operation, inspection, maintenance, troubleshooting and cleaning of equipment used throughout the VITEK 2 Card Manufacturing and Packaging processes. Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks, AQL inspections, reworks and material reconciliation that goes along with the batch. Contribute to building a positive work environment.

Primary Duties

1. Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs.

2. Ensure that all batch records are completed in an accurate, thorough, and timely manner.

3. Execute validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as required to maintain systems in a validated state.

4. Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.

5. Certified in operation of at least one high speed manufacturing equipment efficiently and effectively, in some cases highly automated, using HMI/SCADA interfaces.

6. Engage in cage/rack movement, maintain product segregation, retrieve and organize raw materials, and ability to learn fork truck operation.

7. Follow appropriate departmental cleaning procedures to ensure adequate cleaning of the manufacturing areas.

8. Setup high speed manufacturing equipment, within defined tolerances, to ensure product runs are started on time and within established guidelines.

9. Comply with all safety policies and procedures at all times.

10. Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.

11. Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements.

12. Perform all work in compliance with company quality procedures and standards.

13. Performs other duties as assigned.

Qualifications

Education:

High School Diploma or GED Equivalent

Experience

No experience required; at least 1 year experience in FDA regulated manufacturing environment and GMP is desired.

Knowledge, Skills, and Abilities

• Technical learning aptitude to quickly understand and acquire new technical knowledge and skills.
• Attention to detail and the ability to accurately interpret technical documentation are critical
• Ability to perform computer applications including learning and performing SAP transactions
• Ability to perform necessary calculations and complex task sequences in order to meet production requirements
• Written Communications - including the ability to communicate technical data in written form
• Effective verbal communication skills
• Effectively navigate social interactions in the workplace
• Participate in a way that enhances team performance and cohesion.

Working Conditions and Physical Requirements

• Ability to remain in stationary position, often standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery.
• Ability to adjust or move objects up to 50 pounds in all directions.
• Ability to stand for 8-12 hours. Ability to work overtime as required to cover a 24/7 operation.
• Extensive standing, repetitive hand and arm motions, ability to climb steps.
• Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded.
• Operating within cool temperature and low humidity conditions within the production room.
• Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment.
• Excellent personal hygiene required.
• Appropriate gowning requirements necessary for the production areas.
• Gloves are required to handle the product. Hairnet, clean room gowns and/or lab coats are required.
• Safety glasses and hearing protection are required personal protective gear.
• Occasional environmental odors may be prevalent