Microbiology Scientist

Microbiology Validation Engineer

The Microbiology Validation Engineer plays a key role in executing and delivering microbiological method validation and laboratory validation activities in support of a cGMP remediation and validation program. This position focuses on ensuring analytical methods are scientifically sound, appropriately validated, and fully compliant with current regulatory expectations in a pharmaceutical or biotechnology environment.

• Lead the validation of rapid microbiological methods, including implementation and optimization of the Neo Gen system.
• Perform method suitability testing across multiple product matrices to confirm that methods are appropriate for their intended use.
• Design and execute comparative studies against compendial USP methods to demonstrate equivalency or superiority of rapid methods.
• Develop and validate dilution schemes and related procedures to ensure accurate and reliable microbiological testing.
• Independently author validation protocols, validation reports, and supporting documentation in accordance with cGMP and regulatory guidelines.
• Prepare and perform risk assessments related to microbiological methods, laboratory processes, and validation activities.
• Investigate and document deviations, identify root causes, and propose effective corrective and preventive actions.
• Apply working knowledge of 21 CFR Parts 210 and 211, Data Integrity principles, and pharmaceutical laboratory cGMP requirements in daily work.
• Collaborate closely with Operations, Quality, and Leadership teams to align validation activities with business and compliance objectives.
• Explain regulatory and validation requirements in practical, business-focused terms to non-quality personnel to support understanding and adoption.
• Influence stakeholders without direct authority and build consensus on validation strategies, procedures, and documentation requirements.
• Support the development and improvement of quality systems in organizations with low process maturity or evolving quality frameworks.
• Balance compliance objectives with operational realities while ensuring adherence to regulatory expectations.
• Contribute to process validation efforts and related IQ/OQ activities where microbiological methods and laboratory systems are involved.

• Bachelor's degree in Microbiology, Biology, Chemistry, or a closely related scientific field.
• 3–7+ years of experience in pharmaceutical or biotechnology validation roles.
• Demonstrated experience developing and executing microbiological method validations in a cGMP-regulated environment.
• Strong hands-on experience with microbiological method validation, including design, execution, and documentation.
• Proficiency with USP and other compendial microbiological methods and their application in pharmaceutical testing.
• Experience with rapid microbiological systems and rapid microbial methods, including validation and comparative testing.
• Proven ability to independently author validation protocols, validation reports, risk assessments, and deviation investigations.
• Working knowledge of 21 CFR Parts 210 and 211 and their application to pharmaceutical manufacturing and laboratory operations.
• Solid understanding of Data Integrity principles and pharmaceutical laboratory cGMP requirements.
• Experience with validation testing, process validation, and related IQ/OQ activities in a regulated environment.

• Experience working in organizations with low process maturity or developing quality systems, with the ability to help build and refine processes.
• Ability to explain complex regulatory and validation requirements in clear, practical, and business-oriented language to non-quality stakeholders.
• Skill in influencing stakeholders without direct authority and building consensus across Operations, Quality, and Leadership teams.
• Patient and adaptable approach to implementing change in environments that may be resistant to new procedures and documentation requirements.
• Strong ability to balance compliance objectives with operational realities while maintaining regulatory expectations.
• Excellent written and verbal communication skills for…