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!
1. PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB:
The primary purpose of this position is to prepare complex chemical media and/or sub components, dispensing system setup/verifications, insuring timely delivery of high quality product to Card production, being current on training including curriculum procedures, work station organization and cleaning, establishing a safe work environment, housekeeping and maintenance functions in the production department.
2. CONTEXT OF THE JOB AND MAJOR CHALLENGES:
The major challenge will be to fulfill all production scheduling needs and to provide high quality product in order to meet customer specifications and ship dates. This job involves the direct formulation of the media component used in manufacturing of the bioMérieux disposable product and the setup of the dispensing system. Routine internal contacts include Maintenance, Manufacturing, Materials, Quality, Research & Development, Industrialization, and Engineering.
3. DIMENSIONS OF THE JOB
Decisions involving operations in the production laboratory are made daily. 1. The number of wells and/or lot of product/sub component produced on schedule. 2. Timely delivery of product to the pour station. 3. The number of tech errors leading to NCMRs and/or Lot loss. 4. The number of back orders for product not available to ship on time.
4. MAIN ACCOUNTABILITIES
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 MES (Manufacturing Execution System) 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, MES 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.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
1. Bachelor of Science degree in Biology/Chemistry or 6 years equivalent laboratory experience is required.
2. A minimum of one (1) year 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:
- Safety glasses - Clean room gowns and/or lab coats - Etc. • 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. • Reasonable, reliable attendance and punctuality is an essential job function required for this position. • Must be able to lift up to fifty (50) pounds