Manufacturing Tech 2-Night Shift

Description

Position Summary:

The Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner. The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT 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

Responsibilities:

1. Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces

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

3. Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner

4. Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations

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

6. Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns

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

8. Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.

9. Perform self-audit of rooms and processes

10. Train and certify teammates on production processes and procedures

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

12. Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making

13. Work with other departments and assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state

14. Perform computer applications including learning and execution of SAP transactions

15. Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all of our customer requirements

16. Assess when manufacturing or quality issues require escalation to senior staff or management to promptly address potential impacts on business continuity.

17. Executing tasks accurately and efficiently is fundamental to meeting customer expectations and maintaining business continuity. Any disruptions in workflow directly impact production targets, affecting customer satisfaction and, ultimately, the company’s financial health.

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

19. Performs other duties as assigned.

Qualifications:

High School Diploma, GED or equivalent required

Minimum of 1 years of relevant experience in a regulated production/operations environment, OR Equivalent military experience required

Certification in a Bioworks Program or equivalent is preferred

Minimum of 1 years of relevant experience in a regulated production/operations environment, OR Equivalent military experience required

BioWorks, LEAN or other Continuous Improvement Certificate preferred

Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.

Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.

Knowledge of FDA and/or GMP regulations preferred.

Mechanical background preferred.

Detail orientation to complete tasks without errors and produce high-quality work.

Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently

Informing others by sharing clear, timely information to ensure alignment.

Easily accessible and open to communication

Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes

Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns.

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.

May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches away

May be exposed to Chemical Hazards and require the handling of chemicals, antibiotics and/or hazardous materials.

May be exposed to strong odors incurred during media production or other operations.

Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.