Scientific and technological innovation is at the heart of bioMérieux's strategy. A world leader in the field of in vitro diagnostics for more than 45 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.
bioMerieux is an Equal Opportunity , Affirmative Action Employer. M/F/D/V
2nd shift position.
The primary purpose of this position is to perform the aseptic filling operations within the fill room department. In addition, the operator is responsible for performing labeling and packaging functions that also take place in the fill room. Additional functions include bottle production and final packaging stages in the packaging areas.
This position will routinely interact with various internal departments or functions involved with the Manufacturing, Packaging and/or testing of our products. The major challenge will be to fulfill all production scheduling needs and to provide quality product in order to meet customer specifications and ship dates.
• Aseptically prepares media for the filling operation, which includes batching media into carboy containers, siphoning glassware, adding sterile ingredients to appropriate products.
• Performs filling operations, which include start up, calibration of systems and scales, and in-line quality checks. Also, performs minor troubleshooting functions on automated filling equipment, pumps and heat sealers.
• Sanitizes all product contact areas on appropriate manufacturing equipment on a daily basis. Then sets up and operate all automated filling, labeling and packaging equipment.
• Documents all necessary information on the work orders, which include the following, but is not limited to: Lot numbers and suppliers for additive solutions, equipment used and there respective ID #’s, plate label information, label reconciliation, and line clearance before the start and after completion of filling and/or packaging operations for each batch by inspecting the filling equipment for excess units and labels. All documentation practices are to follow all appropriate cGMP’s.
• Maintains physical separation of batches by using separate tables, carts or physical barriers and applying signs to identify batches that are in process.
• Cleans stainless steel containers, kettles, tube sets, etc. that may be used in the fill room and compounding departments. Tube sets and associated components will be wrapped and prepared for re-sterilization for the subsequent day.
• Obtains and documents all materials required from inventory. Checks inventory supply levels and notifies the Production Manager for re-ordering.
• Transports glassware and kettles containing prepared culture media to the fill room. Connects kettles to filling equipment.
• Performs end-of-shift or end-of-day shut down. Turns off all equipment that will not be used between shifts or turns off at the end of final shift. Removes garbage from the fill room and places in appropriate dumpster.
• Perform plate, tube and bottle packaging functions. This may include but is not limited to packaging plates into appropriate boxes, unloading bottled product from autoclave carts, labeling bottled product, retorquing and applying shrink seals.
• Performs bottle production - Inspects, cleans and assembles equipment and calibrates scales. Obtains and documents all materials required from inventory. Rinses and inspects bottles prior to filling when applicable. Fill bottles either manually or through automated system. Prepares product for sterilization.
• Performs quarterly and semi-annual cleaning of entire facility (i.e. washing walls, ceilings, coolers, equipment, etc). Follows instructions provided by internal Standard Operating Procedures and/or work orders that are issued from the Engineering Department.
• Saturday work may be required.
• Performs other duties as requested.
• Requires a High School Diploma or equivalent and 0-2 years experience in the field or related area. Relies on experience and judgment to plan and accomplish goals.
• Knowledge and experience of Good Manufacturing Practices (GMP’s), ISO 9001:2000 and FDA regulations is highly recommended.
• Requires the ability to multi-task and maintain focus.
• Mental alertness with regard to process parameters, accuracy and safety.
• Ability to follow written and oral directions.
• Must be able to communicate with others related to daily execution of production.
• Good written and verbal skills
• Good math skills. Good understanding of mathematical conversions (i.e. milligrams to grams to kilograms or milliliters to liters etc)
• Good mechanical aptitude and skills.
• Extensive standing and repetitive hand and arm motions.
• Lifting and moving pales, boxes and kettles up to 50lbs may be required. Handling and moving warm articles from the water bath will be necessary.
• Operating within cool temperature conditions within the fill room. Constant low-level noise is common due to the operation of the filling equipment.
• Excellent personal hygiene required. Appropriate gowning requirements necessary for the various departmental areas. Gloves, masks, hairnet, clean room gowns and/or lab coats are required for some procedures.
• Occasional environmental odors may be prevalent.
• Company manufactured products may contain sterile animal blood.***
Biomerieux - 16 months ago
bioMérieux is a leading international diagnostics group that specialises in the field of in vitro diagnostics for clinical and...