Microbiologist: Becton Dickinson & Company (BD)

Under the supervision of the Sterilization QA Lead, perform microbiological and tissue culture tasks as well as sterility and bioburden tasks associated with new or modified products or processes, contamination control and documentation of sterilization operations.

Support his/her team by taking an active role in problem solving tasks, team activities and team and plant-wide subgroups focusing on the plant goals of safety, quality, schedule, schedule and cost.

ESSENTIAL JOB FUNCTIONS

Support the Sterility Maintenance Program by performing sterility testing on product and media and interpreting data accordingly.

Responsible to verify sterilization dose for products meet requirements, then release product to next stage of distribution.

Support the LAL Pyrogen Testing Program for all applicable product lines by conducting pyrogen testing and interpreting data accordingly.

Support the Tissue Culture Testing Program by performing routine cell line maintenance and conducting tissue culture confluency testing and/or clonogenic testing.

Support the environmental monitoring program. This includes assisting in the coordination of clean room certifications and associated personnel. Duties will include test performance.

Perform and report trend analyses of laboratory test results, lot failures, DHR review and product release.

Perform Measurement System Analysis and validation of laboratory equipment. Assist in developing and validating protocols for laboratory testing of products and materials.

Assist in develop and maintaining work instructions for laboratory testing of products and materials.

Provide technical guidance and educational training to manufacturing in the area of microbiological testing and environmental practices.

Work closely with the Sterilization QA Lead to review technical problems, suggest solutions and anticipate major problems to key operations.

Coordinate analysis of microbial and environmental product/process problems using communications with production personnel and laboratory.

Maintain accurate and current records of all results and procedures. Must be able to assure a high degree of accuracy in all tests results obtained.

Coordinate the collection and set-up laboratory test samples according to documented procedures.

Manage and monitor the performance of routine preventative maintenance and monitoring of laboratory equipment and supplies.

Perform other tasks as assigned.

KNOWLEDGE, SKILLS, AND ABILITIES

Must be action oriented with the ability to adapt and learn from arising opportunities.

Excellent organizational and multi-tasking skills. Excellent written and oral communication skills, with attention to detail.

Must be an active, engaged team worker as well as team leader with the ability to prioritize work and influence people outside of area of responsibility.

Experienced in microbiological techniques, sterilization processes, ELISA and tissue culture techniques.

Ability to bring in new testing methods, such as Dnase / Rnase and mouse embryo testing is desired, but not required.

Understanding of ISO9000 and Quality System Regulations pertaining to a manufacturing facility and associated quality system documentation.

Must have a good working knowledge of word-processing, spreadsheets and database applications. Experience in SAP is preferred.

Ability to develop and maintain a high performance work team culture focusing on the plant goals of safety, quality, schedule, cost and team development.

MINIMUM QUALIFICATIONS

BS degree in Microbiology (preferred) or in the Biological Sciences with 5 years experience in Microbiology.

Five (5) years of microbiologist experience, preferably in a medical device industry.

Must be experienced in microbiological techniques with an in-depth knowledge of either radiation sterilization processes or tissue culture techniques. Both would be preferred.

Minimal travel may be required.