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Manufacturing Tech - Night Shift
BioFire Diagnostics, LLC. • Durham, NC 27722 • Posted 8 days ago
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In-person • Full-time • Entry Level
Job Highlights
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The Manufacturing Technician at BioFire Diagnostics, LLC 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. This role involves operating high-speed manufacturing equipment, ensuring compliance with all job-related SOPs, maintaining cleanliness and organization of work areas, and assisting with quality control and safety procedures.
Responsibilities
- Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
- Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs
- 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
- 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
- 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
Qualifications
Required
- High School Diploma or GED
- 0 years of experience
Preferred
- Certification in a Bioworks Program or equivalent
- Demonstrated proficiency in the operation of high speed, highly automated, production equipment
- Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.)
- Knowledge of FDA and/or GMP regulations
- Mechanical background
Full Job Description
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 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.
Primary Responsibilities:
+ Production:
+ Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
+ 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
Education, Skills, & Experience:
+ High School Diploma or GED Required with 0 years of experience required
+ Certification in a Bioworks Program or equivalent is 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.
#biojobs
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 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.
Primary Responsibilities:
+ Production:
+ Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
+ 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
Education, Skills, & Experience:
+ High School Diploma or GED Required with 0 years of experience required
+ Certification in a Bioworks Program or equivalent is 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.
#biojobs
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