Senior Microbiologist

Edwards Lifesciences

20d • $92,000 - $130,000

About The Position

The Senior Microbiologist provides technical leadership for sterilization, sterility assurance, antimicrobial control, and environmental monitoring programs supporting medical device manufacturing. The role leads cross-functional validation and qualification studies, develops complex microbiological protocols and methods, performs advanced data analysis and trend evaluation, and drives corrective and preventive actions to ensure compliance with regulatory, quality, and Edwards standards. The position serves as a subject-matter expert in microbiological controls and supports continuous improvement across laboratory and manufacturing operations.

The role supports microbiological testing and control programs, including bioburden, sterility, endotoxin, antimicrobial testing, environmental monitoring, in-process solutions, and raw material evaluation. It provides scientific guidance on test methods and unusual or ambiguous data; leads investigations, validations, qualifications, and monitoring activities; and helps ensure laboratory and manufacturing practices meet applicable standards and procedures. The Senior Microbiologist also authors and reviews controlled documents, supports audits and inspections, maintains laboratory equipment readiness, and mentors and trains microbiology staff.

The role requires a bachelor's degree in microbiology or a related field with at least four years of experience in a regulated microbiology laboratory; or a master's degree in microbiology or a related field with at least two years of progressive microbial experience; or a PhD in microbiology or a related field with at least one year of industry experience. Preferred qualifications include relevant microbiology and medical-device testing experience, knowledge of quality and documentation practices, proficiency with Microsoft Office, and experience with laboratory software such as LIMS or WinKQCL.

For California, the base pay range is $92,000 to $130,000 for highly experienced candidates. Pay depends on factors including qualifications, education, and prior experience. Applications are accepted while the position is posted on the Careers website.

Requirements

• Bachelor's degree in Microbiology or a related field and at least 4 years of experience in a microbiology regulated laboratory environment; or a master's degree in Microbiology or a related field and at least 2 years of progressive microbial experience; or a PhD in Microbiology or a related field and at least 1 year of industry experience.
• Apply microbiology principles and standards to regulated laboratory testing, environmental monitoring, validation, and medical-device manufacturing activities.
• Knowledge of Good Manufacturing Practices and Good Documentation Practices in a medical-device environment.
• Ability to communicate and interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Strict attention to detail.
• Adhere to company requirements and Environmental Health & Safety rules, and take adequate measures to prevent injury and pollution within the employee's span of influence or control.

Nice To Haves

• Proven expertise in the MS Office Suite, including Word, Excel, and PowerPoint.
• Experience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, organism identification and characterization, and testing of medical devices, manufacturing processes, systems, and facilities.
• Experience with qualification involving sterilization processes and environmental controls.
• Excellent written and verbal communication skills and interpersonal relationship skills.
• Demonstrated problem-solving and critical-thinking skills.
• Knowledge and understanding of Edwards policies and procedures relevant to microbiology.
• Knowledge and understanding of microbiology principles, theories, and concepts.
• Experience with laboratory equipment software such as LIMS and WinKQCL.
• Advanced problem-solving skills.
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines for department cleanroom medical-device manufacturing.
• Ability to manage competing priorities in a fast-paced environment.

Responsibilities

• Serve as a technical lead or subject-matter expert for microbiological testing, including bioburden, sterility, endotoxin, antimicrobial testing, environmental monitoring, in-process solutions, and raw material evaluation.
• Perform, review, and approve routine and non-routine microbiological testing, ensuring methods are executed correctly and results are scientifically sound.
• Assess method suitability, organism recovery, incubation parameters, media performance, and identification approaches using advanced microbiology principles.
• Provide guidance on atypical results, OOS/OOT trends, and borderline or ambiguous microbiological data.
• Act as the microbiology subject-matter expert for cleanroom and controlled-environment monitoring, including viable and non-viable particulate monitoring.
• Lead and support qualification, validation, and ongoing monitoring of critical systems, including cleanrooms, utilities, and microbiology-related manufacturing systems.
• Establish, justify, and evaluate environmental monitoring alert and action limits; assess excursions and remediation effectiveness.
• Participate in change impact assessments related to environmental controls, disinfection programs, cleanroom design, and manufacturing systems.
• Ensure microbiology activities comply with ISO standards, FDA QSR, GMP, and Edwards quality management procedures.
• Lead microbiology-related investigations, including OOS, OOT, environmental monitoring excursions, and sterility failures; support well-founded root cause analyses and effective corrective actions.
• Apply and reinforce Good Documentation Practices across microbiology records, reports, protocols, and laboratory data systems.
• Identify gaps, inconsistencies, or risks in microbiology processes and initiate corrective actions through established QMS mechanisms.
• Author, review, and approve microbiology SOPs, work instructions, protocols, and reports within the scope of responsibility.
• Apply knowledge of ISO microbiological and sterilization standards to laboratory testing, environmental monitoring, and validation activities.
• Translate regulatory and standards requirements into executable laboratory practices.
• Support internal and external audits and inspections by presenting microbiology data, rationale, and controls accurately.
• Execute and support microbiological method validation and verification activities in alignment with approved strategies.
• Support qualification, calibration, and maintenance of microbiology laboratory equipment.
• Review proposed changes to microbiology methods, equipment, materials, or processes for quality and compliance impact.
• Provide technical guidance and mentoring to technicians, technologists, and junior microbiologists.
• Support training, qualification, and remediation for microbiology methods, aseptic technique, environmental monitoring, and documentation.
• Model scientific rigor, a strong quality mindset, and compliance-focused decision-making.
• Adhere to Edwards Environmental Health & Safety and Quality policies, including cleanroom and medical-device manufacturing requirements.
• Ensure microbiological, hazardous, and biohazardous materials are handled and disposed of according to site and regulatory requirements.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address employees' and their families' diverse individual needs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior