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Job Description Summary Job Description
Be part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.JG3PCP NA Job Summary:Responsible for the sterility assurance of all product manufactured at the Columbus East site. Ensuring the sterilization cycles for EO (Ethylene Oxide) are qualified and compliant with ISO 11135 and the radiation program is compliant to ISO 11137 will be essential. The understanding of the BDM-PS Columbus manufacturing process and how changes could impact Sterilization will be required. Oversight of all contract sterilization sites and processes (EO and Radiation), this oversight will include root cause analysis and product impact assessment for all deviations as they pertain to the sterilization process. Basic understanding of the sterile batch release process and analytical lab processes such as: Environmental monitoring, Endotoxin, Biological Indicator and Product Sterility testing will be necessary. Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values. Responsibilities include but are not limited to:- Ensure that the sterilization processes are compliant to their respective ISO standards; radiation (ISO 11137) and EO (ISO11135).
- Author, support and complete validations and requalification's for EO and Radiation processes.
- Support and perform investigations as it pertains to sterilization. Serve as point of contact for contract sterilization facilities.
- Understand routine laboratory procedures to include endotoxin (water and product), Biological Indicator (BI) testing and placement, environmental monitoring testing and trend analysis, microbial identification, product sterility testing, B/F testing, SDA (Sterilization Dose Audits) and bioburden testing.
- Provide support during on site audits of Sterilization and also support the audits that occur at contract sterilizers.
- Provide technical assessment for changes to current product or new product in terms of Sterilization.
- Support Continuous Improvement activities around Sterilization: cycle time optimization, testing time optimization, safety awareness, new Sterilization site Qualification.
- Develop training for associates involved with sterilization and sterilization processes.
- Review and approval of calibration of the Sterilization Process and Equipment.
- Provide support for customer and regulatory concerns in terms of Sterilization.
- Implements metrics to support the control of the Sterilization process.
- Project Management will occur for Sterilization / Lab project.
- Other duties as required to support the needs of the business.
- Bachelors from a scientific field
- $0 payroll contributions if your salary is below $50,000
- Plan covers 100% preventative care (annual wellness exam, and immunizations)
- Visit any provider
- Competitive pay
- Up to 6 weeks of paid parental leave
- Medical, dental, and vision insurance plans
- Education assistance ($5250.00 per year)
- Adoption assistance
- 401K plan with $.75 of every dollar matched up to 6% of compensation
- Basic life and AD&D provided
- Discounted home, auto, and pet insurance plans
- Paid holidays and vacation (pro-rated the first year based on actual start date)
Vacancy expired!