Posted in Other 30+ days ago.
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Type: Full Time
Location: Fairfield, New Jersey
Together we can make a difference
At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope - just to name a few.
A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.
This position is responsible for the Biocompatibility and sterility of product manufactured and distributed. It will establish programs to ensure appropriate environmental controls are in place for manufacturing and distribution of products. Ensure that all components, manufacturing materials and products are adequately assessed and satisfy biocompatibility and sterility requirements as required.
Primary Responsibilities incudes:
* Maintain periodic sterilization validation requirements for EO per ISO 11135.
* Maintain and improve validated standards of performance for microbiological testing.
* Provide resource to manufacturing and product development teams to address biocompatibility of materials and ability to sterilize.
* Identify, develop, and approve corrective actions for out of compliance issues.
* Provide support to Fairfield departments related to environmental monitoring results.
* Develop and maintain sterilization validation programs, quarterly dose audits and other applicable requirements.
* Responsible for audits of contract sterilizers and associated labs.
* Resolve out of compliance issues.
* Identify and implement cost savings/ process improvement programs.
* Administer LAL test methods in accordance with AAMI ST72 and bioburden test programs.
* Develops and maintains programs for environmental controls (Air, Water, Bioburden, etc.) and manage staff responsible for periodic assessment.
* Supervises Microbiology non-exempt staff, If applicable.
* This is not an inclusive list of job responsibilities.
Required Skills and Abilities:
* A Bachelor of Science in Biology, Microbiology, Chemistry or related field or equivalent is required. A Master of Science is preferable.
* Prior educational background inclusive of courses in toxicology is highly desirable.
* A minimum of five years or more experience managing microbiological studies in a FDA regulated industry or ISO certified organization is required. Five years of experience evaluating pyrogens, water control and/or biomaterials is required. Prior experience managing environmental controls is required.
* Must have demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.
* Must demonstrate a working knowledge of current industry standards.
* Must demonstrate effective organizational skills and ability to manage multiple projects.
* Must have good knowledge of ETO and Gamma Radiation Sterilization.
GETINGE GROUP IS AN EQUAL OPPORTUNITY EMPLOYER AND ALL QUALIFIED APPLICANTS WILL RECEIVE CONSIDERATION FOR EMPLOYMENT WITHOUT REGARD TO RACE, COLOR, RELIGION, SEX, SEXUAL ORIENTATION, GENDER IDENTITY, PREGNANCY, GENETIC INFORMATION, NATIONAL ORIGIN, DISABILITY, PROTECTED VETERAN STATUS OR ANY OTHER CHARACTERISTIC PROTECTED BY LAW.
We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world s most desired medtech company.