Job Description Summary

Under direction of the Sterilization Supervisor, perform analysis of sterilization parameters for product release, perform investigations for out of specification results, and run projects to improve sterilization quality and efficiency

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Responsibilities

• Perform analysis of sterilization parameters for product release and sterilization validations. 

• Perform investigation of out-of-specification results. 

• Evaluate historical data to perform risk assessments. 

• Manage EO sterilization requalification and radiation dose audit programs to ensure continuity of validated processes and regulation compliance. 

• Coordinate annual and quarterly process requalification’s and product verifications (Irradiation & Ethylene Oxide). 

• Author, implement, or review protocols to support sterilization goals. 

• Perform routine analysis of EO/ECH residual testing of terminally sterilized medical using gas chromatography (GC-FID). 

• Support routine quality control testing of medical device. This may include: bioburden testing, sterility testing, endotoxin testing, enumeration, and environmental monitoring.  

• Schedules, conducts, documents, and communicates the results of sterilization and microbiology laboratory tests. 

• Ensures that product is tested in a timely manner, minimizing any impacts to production scheduling. 

• Communicates with stakeholders and team members on product or project status. 

• Participate as a member of special project teams, as assigned, including support of sterilization, QC microbiology, R&D and plant objectives. 

• Lead investigations and author reports of results for non-conformance and CAPAs.  

• Maintains metrics within sterilization in order to promote continuous improvement. 

• Assist in training of new employees. 

• Ensures that good housekeeping practices are followed in the area and participates in scheduled lab cleaning and maintenance activities. 

• Ensures that testing and documentation are performed according to GMP and GDP practices. 

• Authors and revises SOPs utilizing an SAP document management system. 

• Support the quality department by performing internal audits. 

• Follow all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations. 

• Follow all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles. 

• Other duties as assigned. 

Minimum Requirement:

• High School Diploma or GED

• Microbiology or chemistry background preferred

• Experience working i