Location: Lombard, IL, United States
Position Type: Temp
Job Function: Manufacturing
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.
· The Operator 1 position is responsible for the operation of equipment used in the filling and plating of Prepared Culture Media plates, bottle, and tubes in a cGMP compliant manner.
· The individual will perform or assist in the setup, inspection, operation, preventive maintenance, troubleshooting and cleaning of equipment used throughout the Prepared Culture Media filling/bottling processes.
· Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks.
· The individual will also perform all ancillary tasks to support routine production, including area cleaning and 5S, movement of materials, AQL inspections, reworks, material reconciliation, and other tasks deemed necessary by production management.
· Set-up, operate and troubleshoot as needed on various production machines for filling and high-speed packaging of Prepared Culture Media using HMI/SCADA interfaces.
· Operate a manufacturing process within controlled cleanrooms while meeting guidelines for production process flow.
· Perform equipment and component preparation tasks in non-controlled areas to meet batch processing timelines.
· Perform necessary calibrations and verifications of filling and packaging equipment.
· Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs
· Perform ancillary cleaning and sanitization activities of production equipment and areas.
· Ensure that all batch documentation is completed in an accurate, thorough, and timely manner and in accordance with Good Documentation Practices.
· Perform in-process and AQL inspections to meet batch quality requirements.
· 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 accordance with the outlined 5S standards.
· Understand and follow aseptic practices to ensure safety and quality of the products.
· Comply with all OSHA and plant specific safety policies and procedures at all times, inform management of any safety hazards, and attend all required safety training.
· Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
4. Other Duties
· Collect accurate data for reports, charts and KPI's and interpret the data to identify problems and proceed with proper decision making.
· Accurately interpret technical documentation with high attention to detail.
· Assist with executing validation protocols associated with packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state.
· Perform other duties as assigned by Management.
KNOWLEDGE, EXPERIENCE & SKILLS
· Minimum of 2 years in a regulated production/operations environment
· 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 within production environment 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 90-day period of working with a trainer.
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux 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 https://careers.biomerieux.com/ or contact us at [email protected].
BioMérieux 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 BioMérieux’s or its affiliates’ 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).