Job Description: SummaryThe QA Sterilization Engineer is responsible for maintaining the validation programs according to schedule for all of BD Interventional Segment. In addition, the QA Sterilization Engineer manages activities for product assessment for sterilization and monitoring programs.
Schedules and conducts all sterilization validation activities within contract sterilization facilities. Performs cycle development studies and product assessment for sterilization.
Evaluates and dispositions sterilization supplier processing nonconformances.
Ensures compliance to BDI, Corporate, ISO, and EN requirements.
Performs evaluation of new or modified products for sterilization validation equivalency(adoption).
Assist with maintaining processing specifications and procedures as appropriate (SOPs, Pallet Patterns, Sterilization Specification Sheets, Cycle Specifications, etc).
Schedules and conducts sterilization equipment qualification and re qualification.
Writes study protocols and reports as assigned.
Assist in performing sterilization vendor audits.
Oversees sterilization monitoring programs for compliance. (i.e. bioburden, dose audits, etc)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must possess the ability to work independently.
Must be detailed oriented.
Must possess some knowledge about the physical, chemical, and biological sciences.
Must understand government regulated environment and quality systems
Knowledge of hazardous chemical handling. Proficient in the use of a personal computer with intermediate level of keyboarding skills with knowledge of Statgraphics and Microsoft Word, Excel, and Powerpoint.
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and team building.
EDUCATION and/or EXPERIENCE
Bachelor's degree in engineering with emphasis on biological, chemical or related sciences preferred.
Minimum of three years of working experience in quality system regulated industry.
Excellent written and verbal communication skills. Ability to prepare technical reports and write technical procedures. Ability to communicate ideas articulately.
Ability to apply basic mathematical concepts such as algebra and statistics.
Possess strong reasoning skills. Ability to effectively manage daily activities with little supervision. Ability to investigate and interpret internal, domestic, and international standards and guidelines. Determining what is absolutely necessary and ensuring compliance with requirements and parameters.
A high level of initiative is required. Day-to-day decisions regarding projects and validation programs are made frequently. Position may interface with internal and other division employees, contractors, and regulatory agencies.
Primary Work LocationUSA GA - Covington BMD
Additional LocationsUSA NJ - Franklin Lakes
Work ShiftUS BD 1st Shift 830am-5pm (United States of America)
BD (Becton, Dickinson And Company)