Principal Microbiologist - Wayne, NJ - #1400373

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 Getinge's Maquet Cardiovascular Business entity. 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.

This position will be hybrid with 3-4 days onsite.

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 Acute Care Therapies (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 experience managing Sterility Assurance programs in a FDA regulated industry (ISO 11137 and ISO 11135).
• Proven experience managing Bacterial Endotoxin programs ( AAMI ST72).
• 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.
  
  

The bases salary for this position is a minimum of $140,000 and a maximum of $155,000 plus annual bonus (STIP) of 15%

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 products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Getinge 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. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.