What are the responsibilities and job description for the Formulation tech position at bioMerieux?
Benefits at bioMerieux :
Low-cost medical, dental, and vision benefits starting day one
11 paid holidays
160 hours of paid time off
Annual bonus
9.5% 401k company contribution with no vesting period
Tuition reimbursement up to $10,000 per calendar year
Onsite cafeteria with daily food stipend
Position Summary :
Normal working hours : 7 : 00pm - 7 : 30am working a 2-2-3 rotation.
The Process Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT / ALERT bottles and / or preparing and formulating the liquid reagents that fill the finished BacT / ALERT bottle 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.
Primary Responsibilities :
Production :
- Operate high speed manufacturing equipment, in some cases highly automated, using HMI / SCADA interfaces
- Chemical weighing and reagent formulation
- Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs
Quality :
- Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner
- Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations
- Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
- Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns
- Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements
- Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.
- Perform self-audit of rooms and processes
- Train and certify teammates on production processes and procedures
Safety :
- Comply with all safety policies and procedures at all times
- Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
Other Duties :
- Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
- 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
- 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
- Perform computer applications
- 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
Perform other duties as assigned by Management
Knowledge, Skills, & Experience :
- High School Diploma or GED Required with 2 years in a regulated production / operations environment
- Associates Degree in an applicable or Technical field or Vocational / Technical School preferred
- Certification in a Bioworks Program or equivalent is preferred
- A basic chemistry and lab application experience strongly desired
- Background in bulking and / or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired
- Familiarity with measurement scales, mixing, blending, chemical mills, and other formulation manufacturing equipment strongly desired
- Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
- Knowledge of FDA and / or GMP regulations preferred.
- Mechanical background preferred.
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 operate heavy machinery.
- Ability to adjust or move objects up to 50 pounds in all directions.
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PandoLogic. Category : , Keywords : Process Technician
Last updated : 2024-09-24
Salary : $10,000
