Durham, North Carolina
2 days ago
Formulation Tech 2 - Night Shift

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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. 

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 tasksAQL 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 interfacesChemical weighing and reagent formulationExecute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPsQuality:Ensure that all batch paperwork is completed in an accurate, thorough, and timely mannerPerform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulationsProvide 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 concernsMaintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirementsOperate 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 proceduresSafety:Comply with all safety policies and procedures at all timesAppropriately 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 makingWork 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 stateAssist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated statePerform computer applicationsCommunicate with Materials Management, Production Operations, and Quality Control on a daily basis to 
ensure the timely and efficient production of all of our customer requirementsPerform other duties as assigned by ManagementKnowledge, Skills, & Experience:   High School Diploma or GED Required with 2+ years in a regulated production/operations environmentAssociates Degree in an applicable or Technical field or Vocational / Technical School preferred
Certification in a Bioworks Program or equivalent is preferredA 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 desiredFamiliarity with measurement scales, mixing, blending, chemical mills, and other formulation manufacturing equipment strongly desiredKnowledge 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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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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