Senior 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

Responsible for conducting Microbiology Laboratory Operations to meet business needs within the Microbiology Department. Will assist with programs to ensure appropriate environmental and microbiological controls are in place for manufacturing and distribution of products. Help to ensure that all components, manufacturing materials and products are adequately assessed and satisfy microbiological quality and sterility requirements as required.

Job Responsibilities and Essential Duties

Support Microbiology Laboratory Operations :

• Conduct Environmental Monitoring Sampling and Testing such as Viable and Non-Viable Air, Viable Surface and Water Bioburden and Bacterial Endotoxin Testing.
• Conduct Laboratory testing such as Product Bacterial Endotoxin Testing and Microbial Identification.
• Support routine laboratory testing activities
• Provide assistance in maintaining validated standards of performance for microbiological testing.
• Responsible for technical writing and data analysis
• Support Qualification of New Microbiologists

Support Microbiology Quality and Sterility Assurance for Product Design Change and New Product Development :

• Support sterilization validations, revalidations and adoptions (When assigned)
• Support New Product Development (When assigned)
• Support Design Change Assessments for Microbiology, Sterilization and Biocompatibility (When assigned)
• Support Standard Assessments (When assigned)
• Support external lab testing coordination and communication as needed
• Performs and is responsible for investigation and corrective actions for out of compliance issues

Microbiology Quality and Sterility Assurance Organization Awareness :

• Support as Subject Matter Expert with Internal and External Audits
• Participate in cross-functional team meetings representing the department
• Provide technical cross functional guidance
• Provide technical leadership for project team activities, team members, peers, and cross functional counterparts.

Minimum Requirements

• A Bachelor of Science in Biology, Microbiology, Chemistry or related field is required or equivalent experience.
• A minimum of four (4) years or more experience in an FDA regulated industry or ISO certified organization is required.
• Alternatively, a minimum of two (2) years or more experience in an FDA regulated industry or ISO certified organization with a Masters or above in defined educational fields

Required Knowledge, Skills, and Abilities

• Must demonstrate a working knowledge of current industry standards.
• Must demonstrate effective organizational skills and ability to manage multiple projects
• Must possess strong analytical and process skills, and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.

The base salary for this position is a minimum of $110,000 and a maximum of $120,000 plus 10% 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 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.

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