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Formulation Technician, 2nd shift

Biomerieux , Inc. Durham, NC, United States Full-Time
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World leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety. bioMérieux is present in 43 countries and more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France. Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit. We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.

World leader in the field of in vitro diagnostics for over 50 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety. bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France. Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit. We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities. Our Group offers numerous possibilities: so come and join the 10,000 bioMérieux employees who have already identified with these values!

Primary Purpose and Overall Objective of the Job: 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. Main Accountabilities: 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.Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making. Express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders and specifications. 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.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.Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces.Follow appropriate departmental cleaning procedures to ensure adequate cleaning of the manufacturing areas.Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations.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.Proficient in the use of computers and Microsoft Office tools.Perform computer applications.Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements. Demonstrate and work towards developing the following attributes:Being open to change and new information; adapt behavior or work methods in response to new information, changing conditions, or unexpected obstacles.Show understanding, courtesy, tact, concern, and respect to others; develop and maintain positive working relationships with others; may include effectively dealing with individuals who have different viewpoints; relate well to individuals from varied backgrounds. Perform other duties as assigned by Management. Typical Studies-Experience, Skills and Qualifications: Studies-Experience: A High School Diploma or GED equivalent and a minimum of 0-1 years in a regulated production/operations environment (preferably in the pharmaceutical or biotech industry) required.Associates Degree in an applicable or Technical field or Vocational / Technical School preferred. Skills and Qualifications: Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.Knowledge of FDA and/or GMP regulations preferred.Mechanical background preferred. Ability to rapidly learn new procedures and reduce them to practice. Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75 day period of working with a trainer.Ability to work in a team environment with minimum supervision.Physical Requirements:Performs all job functions and responsibilities in a safe and responsible manner. Ability to regularly climb stairs to perform work.Ability to stand for extended periods of time on shifts that could range from 8-12 hours.Ability to routinely lift 20-40 lbs.Ability to work overtime as required to support a 24/7 production operation.Ability to operate motorized pallet jacks.Ability to maintain reliable and punctual attendanceMay be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.May be exposed to strong odors incurred during media production or other operations.Lab work is performed wearing various types of PPE which include but is not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats. Make-up and jewelry are prohibited in certain areas of Manufacturing. bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity
 

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