Senior Microbiologist

Edwards Lifesciences

13d•Onsite

About The Position

Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Microbiologist provides technical leadership for sterilization, sterility assurance, antimicrobial control, and environmental monitoring programs supporting medical device manufacturing. This 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 initiatives across laboratory and manufacturing operations.

Requirements

Bachelor's Degree in Microbiology or related field with significant industry experience, minimum 4 years’ experience in microbiology regulated laboratory environment or
Master's Degree in Microbiology or related field required, with minimum 2 years of progressive microbial experience or
PhD in Microbiology or related field with minimum 1 year industry experience.

Nice To Haves

Proven expertise in MS Office Suite
Experience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, identification and characterization, testing of medical devices, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls.
Excellent written and verbal communication skills and interpersonal relationship skills
Demonstrated problem-solving and critical thinking skills
Full knowledge and understanding of Edwards policies and procedures relevant to microbiology
Full knowledge and understanding of microbiology principles, theories and concepts
Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
Experience with laboratory equipment software (e.g. LIMS, WinKQCL, etc)
Excellent written and verbal communications skills
Advanced problem-solving skills
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Responsibilities

Serve as a technical lead and/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 activities to ensure methods are executed correctly and data are scientifically sound.
Apply advanced microbiology principles to assess method suitability, organism recovery, incubation parameters, media performance, and identification approaches.
Provide authoritative guidance on atypical results, OOS/OOT trends, and borderline or ambiguous microbiological data.
Act as the microbiology SME for cleanroom and controlled environment monitoring programs, including viable and non viable particulate monitoring.
Lead and support qualification, validation, and ongoing monitoring of critical systems (e.g., cleanrooms, utilities, microbiology related manufacturing systems).
Lead and support establishment, justification, and evaluation of EM alert and action limits, excursion assessments, and remediation effectiveness.
Participate in change impact assessments related to environmental controls, disinfection programs, cleanroom design, and manufacturing systems.
Ensure microbiology activities are performed in compliance with ISO standards, FDA QSR, GMP, and Edward’s quality management procedures.
Lead microbiology related investigations (e.g., OOS, OOT, EM excursions, sterility failures), ensuring root cause analyses are well supported and corrective actions are effective.
Apply and reinforce Good Documentation Practices (GDP) across all microbiology records, reports, protocols, and laboratory data systems.
Identify gaps, inconsistencies, or risks within microbiology processes and initiate corrective actions through established QMS mechanisms.
Author, review, and approve microbiology SOPs, work instructions, protocols, and reports within scope of responsibility.
Apply strong working knowledge of ISO microbiological and sterilization standards to laboratory testing, environmental monitoring programs, and validation activities.
Translate regulatory and standard requirements into clear, executable laboratory practices.
Support internal and external audits and inspections by presenting microbiology data, rationale, and controls accurately and confidently.
Execute and support microbiological method validation and verification activities in alignment with approved validation strategies.
Support qualification, calibration, and maintenance of microbiology laboratory equipment.
Review and assess proposed changes to microbiology methods, equipment, materials, or processes for quality and compliance impact.
Provide hands on technical guidance and mentoring to technicians, technologists, and junior microbiologists.
Support training, qualification, and remediation activities for microbiology methods, aseptic technique, environmental monitoring, and documentation.
Model strong quality mindset, scientific rigor, and compliance focused decision making.
Adhere to all Edwards Environmental Health & Safety and Quality policies, including cleanroom and medical device manufacturing requirements.
Ensure proper handling and disposal of microbiological, hazardous, and biohazardous materials in accordance with site and regulatory requirements.