Senior Microbiologist

How you will make an impact

• 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 Edwards' 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.

What you'll need (Required)

• 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.

What else we look for (Preferred)

• 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)
• 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