Scientific and technological innovation is at the heart of bioMérieux's strategy. A world leader in the field of in vitro diagnostics for 50 years, bioMérieux designs, develops, produces, and markets diagnostic systems for medical and industrial applications. bioMérieux's solutions (reagents, instruments, software, and services) are used to determine the source of disease and contamination to improve patient health and ensure consumer safety.
To fulfill its mission to improve public health worldwide, bioMérieux is present in more than 150 countries through 41 subsidiaries. Its world headquarters are located in the Lyon area in France.
We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.
The primary purpose of this position is to prepare complex chemical media and/or sub components, dispensing system setup/verifications and insuring timely delivery of high quality product to Card production. Rapidly learn new procedures and reduce them to practice. Secondary and tertiary functions may include but are not limited to work station organizing, safety, housekeeping and maintenance functions in the production department.
1. Perform all work in the Production Department in a safe manner in accordance with the company policy and/or procedure.
2. Perform and document all manufacturing steps and verification as described in company procedures\policies for the following, but not limited to:
a. Insure Media and/or sub component preparation is completed in a timely manner for prompt product delivery to pour station based on production schedule.
b. Filtrations – including checks to ensure that correct filters are used according to policy/procedure
c. Verify that all media is appropriately labeled and stored based on all regulatory and Master Formulary specifications
d. Proper Equipment (kettles, etc) operation and Clean-In-Place (CIP) operation
e. Calibrations of instruments, scales and meters as needed
f. Media dispense setup (setting the pump dispense volume, placing the dispense head and verifying connections and bag numbering to avoid switched wells)
3. Assist with end of lot documentation review for Device History Record - Master Formulary, etc. All documentation practices are to follow all appropriate procedures\policies. This includes but is not limited to the following:
a. Generate any needed Formularies from the office PC or NEXXIS as needed for production
b. Process order checks for correct raw materials – including data entry and verifications in SAP as needed or delegated by Lead.
c. Accuracy and verification checks - Operator/Observer signatures, Manufacture and/or Hang time reports,
d. Supporting documentation – weigh tapes, pH meter tapes, NEXXIS reports, well-remake reports, etc.,
4. Maintain a clean and orderly work environment by following the standards set forth in department 5S guidelines - before, during and after production runs. This includes but not limited to:
a. Cleaning and organizing lab workspace,
b. Cleaning instrumentation/equipment,
c. Sweeping and/or mopping floor as needed,
d. Organizing and maintaining workstations according to 5s principles,
e. Any unspecified actions required to maintain 5s compliance.
5. Inspect and insure all equipment is calibrated and in working order before performing any manufacturing task. Inform Line Maintenance and Group Lead of any items found in need of repair immediately to prevent production delays. Perform start up and shut down procedures for the Lab equipment as described in company procedures\policies.
6. Participate in the new product development and assist with new product transition to production from R&D and Industrialization as required.
7. Maintain adequate inventories of general lab supplies and place purchase orders or inform department’s designated purchasing resource when necessary. Maintain FIFO for all long-term stocks, broths and chemical components.
8. Reasonable, reliable attendance and punctuality is an essential job function required for this position.
9. Performs other duties as requested by Group Lead or management.
1. Bachelor of Science degree in Biology/Chemistry is required.
2. A minimum of one (1) wet chemistry and/or bench work experience preferred.
3. Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands.
4. Excellent problem solving, time management and laboratory skills.
5. Ability to work independently and in groups.
6. Knowledge of sterile techniques and general laboratory procedures.
7. Working knowledge of GLP/GMP and ISO guidelines.
8. Strong PC skills (MS Office – Excel, Word, PowerPoint, Outlook; SAP desired).
• Most laboratory work performed standing.
• Excellent personal hygiene required. Appropriate gowning requirements necessary for the production areas:
o Safety glasses
o Clean room gowns and/or lab coats
• Other protective equipment including latex gloves is used.
• Hazardous chemicals are sometimes used in the production process and additional personal equipment is required.
• Occasional environmental odors may be prevalent.
• May be required to work extended and/or overtime hours.
• Must be able to lift up to fifty (50) pounds.
Equal opportunity/Affirmative Action Employer M/F/D/V
BioMérieux continues to solidify itself as a world leader in the field of in vitro diagnostics.