Formulation Tech 2 - Day Shift - Biofire
Durham, NC
About the Job
Benefits at bioMerieux:
Low-cost medical, dental, and vision benefits starting day one
11 paid holidays160 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: 7:00am - 7:30pm working a 2-2-3 schedule.
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.
Low-cost medical, dental, and vision benefits starting day one
11 paid holidays160 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: 7:00am - 7:30pm working a 2-2-3 schedule.
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.
- 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
- 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
- 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
- Formulation experience and background in bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is highly desired
- Familiarity with measurement scales, mixing, blending, chemical mills, and other formulation manufacturing equipment strongly desired
- 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
- 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 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.
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Source : Biofire
