Finished Goods Manufacturing Automation Machine Operator - D Shift

Description

The Manufacturing Automation Machine Operator is responsible for manufacturing quality products efficiently, accurately, safely and on time. Utilizes high volume automated equipment and in-process instrumentation to manufacture regulated products in accordance to current Good Manufacturing Practices (cGMP), company policy and safety regulations. Works on assignments that are routine in nature where ability to recognize deviation from accepted practice is required. Position requires a wide degree of attention to detail and fine motor dexterity. 

Principal Job Duties and Responsibilities:

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Sustain efforts in the area of responsibility and organization. Develop a thorough understanding of the assigned production areas in order to identify improvement opportunities.
3. Maintain records in compliance with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.
4. Use electronic documentation systems.
5. Execute daily demand based off the production schedule.
6. Act as a catalyst for positive change.
7. Maintain organization and cleanliness of assigned production area.
8. Perform routine cleaning and preventative maintenance of assigned equipment.
9. Assist Engineering in machine repairs or other tasks as/if needed.
10. Operate automated production equipment.
11. Load and unload raw materials and subassemblies.
12. Responsible for ordering Kanban items and maintaining stocks of critical raw materials and sub-assemblies, including monitoring of expiration dates.
13. Work on assignments that are routine in nature where ability to recognize deviation from accepted practice is required.
14. Perform in-process testing to ensure product meets specifications
15. Provide training when necessary to new machine operators in your area.
16. Perform additional tasks as assigned by management.
17. Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR). 

Qualifications

Training and Education:  Requires a high school diploma or equivalent. 

Experience: 

Internal Applicants: Minimum of one year of manufacturing experience at BioFire Diagnostics.  Consideration will be given to applicants with less than one year of internal manufacturing experience if prior machine operator experience in a regulated manufacturing environment can be shown.  

External Applicants: Minimum of 2 years as a machine operator in an FDA/ISO regulated manufacturing environment is required.  Experience with electronic documentation systems is preferred. 

Skills:  Must have good reading, writing, and oral communication and comprehension skills.  Must have a high attention to detail.  Must have good math skills.  Must be able to work in a team environment and have a positive, professional manner.  

Physical Requirements:  Be able to safely lift and maneuver up to 50 lbs., stand for extended amounts of time, squat, bend, kneel, reach, twist, turn, and have fine motor dexterity.