Senior Microbiologist

Job Title:

Senior Microbiologist Job Description The Senior Microbiologist serves as a Senior leader within Biological Quality Assurance in a GMP-regulated Quality Laboratory. This role leads, reviews, and analyzes microbiological and environmental monitoring test results, ensuring compliance with GMP, internal procedures, and applicable FDA and ISO standards. The Senior Microbiologist provides on-the-floor support to both manufacturing and laboratory operations, drives contamination control and aseptic best practices, and collaborates cross-functionally at local and global levels to support continuous improvement in product and environmental quality. Responsibilities Lead and influence team members by providing on-the-floor support for both manufacturing and laboratory operations, ensuring adherence to safety rules, aseptic techniques, and microbiological controls. Troubleshoot and resolve microbiological issues in real time to support uninterrupted production and maintain control of the manufacturing environment. Understand, implement, and maintain GMP requirements for laboratory records, procedures, and systems, ensuring full compliance with procedural and regulatory expectations. Develop and implement strategies to drive performance while maintaining best-in-class aseptic techniques within QC Microbiology and Operations. Track and trend microbiological and environmental monitoring performance data, interpreting results to determine conformance with environmental, personnel, and product specifications. Collaborate with cross-functional teams to investigate and resolve microbiological issues and deviations, identify root causes, implement corrective actions, and prevent recurrence through continuous improvement initiatives. Review and verify microbiological data generated by others to determine conformance with product specifications and support continuous improvement in methods and processes. Assist with the development and delivery of microbiology-related training programs, including aseptic operator training, and ensure staff understand the rationale behind microbiological controls. Lead and take a proactive role in the design, qualification/validation, and maintenance of critical aseptic technique-related processes and studies. Provide oversight of the environmental monitoring program, including design and maintenance of monitoring plans for cleanrooms, water systems, and compressed air systems. Review routine and process environmental monitoring data, water system data, and compressed air results for trends, and support identification and implementation of appropriate corrective and preventive actions. Assist in training, retraining, and competency assessment of employees in microbiological techniques, aseptic practices, and environmental monitoring procedures. Identify contamination risks in production and laboratory areas and drive improvements to reduce contamination risks on the shop floor in close cooperation with Manufacturing and Facilities/Maintenance teams. Understand FDA and ISO standards applicable to the department and apply this knowledge to daily activities, recognizing the consequences of nonconformance. Support the implementation of performance metrics related to microbiology and environmental monitoring, and drive improvement against these metrics. Participate in the review, revision, and implementation of standard operating procedures (SOPs) related to microbiology, aseptic processing, and environmental monitoring. Maintain a clean, neat, and orderly work area, ensuring laboratory equipment and storage areas meet GMP and biosafety expectations. Work cooperatively with manufacturing, quality control, quality assurance, field quality, shipping, and receiving to ensure alignment on microbiological quality and contamination control. Perform other duties and responsibilities as assigned by Laboratory Services leadership to support departmental and organizational goals. Essential Skills Bachelor's degree (BS) from a four-year college or university, or an equivalent combination of education and experience, preferably in Microbiology. Minimum of 5 years of work experience in a medical device, biopharmaceutical, pharmaceutical, food manufacturing, or other GMP production or quality organization. At least 5 years of microbiology experience with environmental monitoring in a GMP environment. Experience in microbial contamination control, including in-depth knowledge of microbiological techniques, aseptic processing, and environmental monitoring. Proven experience building or modifying an environmental monitoring program within a manufacturing facility. Strong practical command of multiple microbiological laboratory techniques, with the ability to perform them with minimal error. Demonstrated ability to work cross-functionally with manufacturing, quality control, quality assurance, laboratory, and facilities teams. Working knowledge of FDA and ISO standards applicable to microbiology, environmental monitoring, and contamination control. Ability to interpret, trend, and analyze microbiological and environmental monitoring data to determine conformance and identify improvement opportunities. Strong communication skills with the ability and interest in teaching others microbiological techniques and explaining their importance. Ability to conduct oneself in a polite, helpful, and professional manner with colleagues at all levels and in all departments. Ability to accept direction from leadership and interact cooperatively with coworkers, supervisors, and managers from other departments. Capability to work effectively in an evolving environment and adapt to changes in work schedule and priorities. Additional Skills & Qualifications Master of Science (MS) in Microbiology is preferred. Experience in pharmaceutical, medical device, or food manufacturing cleanroom environments. Experience supporting or collaborating with field quality and logistics functions such as shipping and receiving. Understanding of the source, composition, and characteristics of products and associated microbiological, chemical, and biosafety hazards. Experience designing and executing qualification and validation studies for aseptic processes and environmental monitoring systems. Experience leading or contributing to SOP review and revision processes in a regulated environment. Interest in growing into a broader or global program support role as environmental monitoring and microbiology programs expand to additional sites. Strong organizational skills to maintain laboratory and storage areas in a clean, neat, and orderly manner. Work Environment The Senior Microbiologist works within a GMP-regulated quality laboratory that closely interfaces with manufacturing and other quality functions. The role involves regular collaboration with Quality Control, Quality Assurance, Manufacturing, Field Quality, Shipping, and Receiving teams. The schedule is a Monday through Friday, first-shift role, totaling 40 hours per week, with flexible hours on day shift and no routine holiday or weekend work, making it well-suited for professionals transitioning from 24/7 manufacturing support environments. The position operates in cleanroom and controlled environments with active environmental monitoring, aseptic processing, and contamination control programs. The laboratory and manufacturing areas are undergoing a multi-year upgrade, including a major overhaul of lab space and dedicated environmental monitoring and microbiology rooms, and the Sr Microbiologist will play a key role in ensuring these areas are designed and implemented appropriately for microbiological operations. The work environment emphasizes GMP compliance, FDA and ISO alignment, safety, aseptic technique, and continuous improvement, with opportunities to support additional sites and potentially evolve into a global program role over time. Job Type & Location This is a Permanent position based out of Peachtree Corners, GA. Pay and Benefits The pay range for this position is $60000.00 - $90000.00/yr. Healthcare, Vision, Dental, 401k, Paid Time Off Workplace Type This is a fully onsite position in Peachtree Corners,GA. Application Deadline This position is anticipated to close on May 20, 2026. 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