Formulation Tech 2

2 weeks ago

Durham, United States bioMerieux Inc. Full time


Formulation Tech 2 - Day Shift


Location: Durham, NC, United States

Position Type: Unfixed Term

Job Function: Manufacturing



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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.



Description

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.
  • 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
  • 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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Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at .


BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. 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 BioMerieux‘s or its affiliates‘ application process by contacting us via telephone at , by email at , or by dialing 711 for access to Telecommunications Relay Services (TRS).



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