Microbiologist

Job Responsibilities

• Perform microbiological testing, including air, water, and product sampling.
• Analyze microbiological data for product release (e.g., bioburden, endotoxin, sterility).
• Develop and manage sitewide microbiological testing schedules.
• Maintain inventory of microbiology plates, reagents, and consumables.
• Manage change controls, deviations, and out-of-specification investigations.
• Train team members on microbiological testing procedures and update relevant QC protocols.
• Oversee test method transfer and validation for microbiological applications.
• Provide support during audits and inspections, offering relevant data and documentation.
• Work with internal teams and stakeholders to address and resolve quality issues.
• Participate in technical meetings with clients to ensure quality standards are understood and met.
• Comply with safety standards and personal protective equipment (PPE) requirements.
• Participate in internal and technical training programs.
• Work onsite, including in cleanroom environments, with potential for off-shift support and occasional travel.

Qualifications

• Bachelor’s degree in Biology, Microbiology, or a related field.
• 3 years performing microbiological testing, including method development and transfer in regulated environments.
• Strong communication, problem-solving, and project management abilities.
• Proficient in QMS processes, validation practices (IQ/OQ/PQ), and root cause analysis for OOS results.