Principal Microbiologist - Wayne, NJ

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

This position is responsible for maintaining company policy and strategies with respect to product cleanliness, sterilization, biocompatibility, and cleanrooms used for product manufactured and distributed by Maquet Cardiovascular. Additionally, he/she will support new product development, collaborating with Product Development and suppliers to provide design inputs as well as to validate sterile, non-sterile and reusable products. This individual’s duty will also include working with Supply Chain to establish, validate and maintain clean manufacturing environments, processes, and utilities. He/she will be responsible for compliance to applicable Quality Regulations, ISO, and AAMI standards.

 

Job Responsibilities and Essential Duties

• Maintain sterilization validation program
• Maintain product Microbiological Quality programs, e.g., Bioburden, and Bacterial Endotoxin
• Maintain Cleanroom controls and compliance programs as it relates to product microbiological quality
• Support manufacturing to ensure continued Microbiological Quality and Sterility Assurance of the device.
• Identify, develop, and approve corrective actions for out of compliance issues.
• Support new product development activities as it relates to Microbiological Quality and Sterility Assurance
• As needed, support biocompatibility compliance of device/materials.
• Ensuring State of the Art compliance with industry standards and guidance
• Ensure that all employees that report to this position are trained to do their work and that their work and training is properly documented.
• Support organization quality objectives and initiatives
• As needed, provide technical guidance to ACT businesses for Microbiological and Sterility Assurance

 

Minimum Requirements, Knowledge, Skills and Abilities

 

• Bachelor of Science in Biology, Microbiology, Chemistry, or related field is required.

• A Master of Science is preferable. 
• A minimum of eight (8) years or more experience managing microbiological studies in a FDA regulated industry or ISO certified organization is required.
• Five years of experience evaluating pyrogens and water control 
• Prior experience managing environmental controls is required.

• Must have experience coordinating and directing suppliers or technicians involved in microbiological, biocompatibility, and sterilization assurance testing,
• 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.

 

 

140,000-155,000 + 15% STIP

 

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About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes pr