Senior Microbiologist: Sterility & Environment Lead

Edwards Lifesciences Gruppe; United States; On-site; USD 92,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences Gruppe is seeking a Senior Microbiologist to provide technical leadership in sterilization, sterility assurance, and environmental monitoring for medical device manufacturing. You will lead cross-functional validation studies, develop complex microbiological protocols, and drive CAPAs to ensure regulatory and Edwards standards compliance.

The role requires strong expertise in bioburden, endotoxin testing, and EM programs, with demonstrated ability to guide teams, analyze

Qualifications

• Bachelor's degree or higher in Microbiology or related field with relevant industry experience.
• Master's degree with progression in microbial field or PhD with practical industry exposure.
• Strong knowledge of ISO microbiological and sterilization standards is required.

Responsibilities

• Serve as microbiology SME for testing, environmental monitoring, and manufacturing systems.
• Lead qualification, validation, and ongoing monitoring of cleanrooms and related systems.
• Support audits, investigations (OOS/OOT), and GMP/ GDP compliance in microbiology labs.

Skills

MS Office Suite

Aseptic techniques

Communication skills

Problem-solving

Education

Bachelor's degree in Microbiology or related field

Master's degree in Microbiology or related field

PhD in Microbiology or related field

Tools

LIMS

WinKQCL

Job description

Edwards Lifesciences Gruppe is seeking a Senior Microbiologist to provide technical leadership in sterilization, sterility assurance, and environmental monitoring for medical device manufacturing. You will lead cross-functional validation studies, develop complex microbiological protocols, and drive CAPAs to ensure regulatory and Edwards standards compliance.

The role requires strong expertise in bioburden, endotoxin testing, and EM programs, with demonstrated ability to guide teams, analyze