Website BD Medical/ BD Pharmaceutical
Job Description Summary
Responsible for finished product releases (steam, EO, radiation); validation of sterilization processes; environmental monitoring, control, and reporting; release of raw materials and work in progresss based on microbial and pyrogen testing; review and maintenance of related procedures, specifications, and work instructions; writing validation protocols; overseeing testing; writing summaries; and reporting trends. Position reports to Laboratory Manager.
Sterilization Support – Working knowledge of sterility testing theory and practice, sterilization technology, and microbiological testing techniques, including endotoxin testing, and environmental viable and non-viable contaminants and aseptic filling techniques. Good Understanding and working knowledge of CGMP’s, USP, ISO, and FDA regulations with regards to WFI, terminal sterilization, aseptic filling and device and/or pharmaceutical processing. Demonstrated ability to lead, develop, comprehend, and manage procedures and specifications related to sterilization processes (steam, EO, and radiation), and water systems.
Microbial Testing – Experience in microbiological testing in laboratory environment. Perform other testing/projects as directed and/or as specified in the plant Quality System. Provide guidance to laboratory technicians in microbial testing and aseptic technique.
Product Disposition – Responsible for finished product releases (steam, EO, radiation) lots based on the monitoring of critical processing parameters and/or testing results. Release of raw materials and work in progress based on microbial and pyrogen testing. Support resolution of material and product non-conformances.
Laboratory Work Environment – Maintain general cleanliness of laboratory. Responsible for proper disposal of tested product, microbiological wastes, and chemical wastes. Completion of OSHA Right-To-Know training is required. Demonstrate the ability to work independently, without direct supervision.
Policies and Safety – Associate must comply with all Quality Assurance, Laboratory, Safety, and other Management Policies and Standard Operating Procedure (SOP’s). Must read and comprehend laboratory, equipment, and Safety procedures related to position.
Technical Writing / Documentation – Must possess excellent technical writing ability. Write and review procedures and test requirements to assure that products are sterile and pyrogen free. Prepare and maintain pertinent paperwork relative to qualification records, sterile product release records, process monitoring reports, and related trending.
Validation – Write protocols and final reports to qualify and/or validate systems to sterilize new products and associated test methods and support other sterilization programs as directed. Oversee testing during initial qualification for environmental monitoring.
Laboratory Support – Support laboratory activities relating to production equipment and process validations. Expected to use good decision making, problem solving and trouble-shooting techniques to minimize the potential of/or to correct ongoing laboratory issues. Procure laboratory equipment, materials, and equipment calibrations as needed.
Training Support – Conduct and support the training and qualification programs for laboratory and production personnel and equipment to perform accurate testing for material and product release based on sterilization requirements and industry standards.
Environmental Support – Oversee ongoing monitoring of environmental and contamination testing. Oversee the plant’s pest control program and HEPA certification program.
Investigation Support – Conducts investigations and investigation reports. Supports the implementation of preventive and corrective initiatives in order to achieve a total quality process. Collects information on laboratory and manufacturing deviations, prepares investigation reports and ensures a quality production flow of product to customers. Develop technical reports to be included in investigation documents.
Supervision / Leadership – Position reports to Laboratory Management (Laboratory Manager), and has no direct authority over others.
Qualifications and Requirements –
- Bachelor of Science Degree in microbiology from a recognized, accredited university or Associate degree in a related sciences discipline with greater than 4 years of QC Laboratory related experience and 12 credit hours in microbiology.
- Demonstrated performance of positive people interactions and team-based environment of continuous improvement.
- Knowledge and Experience: Experience within a device / pharmaceutical manufacturing facility or related laboratory setting, having performed microbiological tasks associated with sterilization and control of microbial contamination on medical and/or pharmaceutical products and processes.
- General computer experience such as but not limited to; MS Word, MS PowerPoint and MS Excel software programs.
- Possess good written and oral communication skills.
- Knowledge of cGMP, FDA regulations, validation, and/or medical device manufacturing experience is desired.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work Location
USA NE – Columbus (West)
To apply for this job please visit jobs.bd.com.