Senior Microbiologist

Senior MicrobiologistTrident Consultant is hiring for a Senior Microbiologist role in Aliso Viejo, CA (Onsite) with one of our industry-leading clients.Position OverviewWe are seeking an experienced Senior Microbiologist to support microbiological activities across Research & Development (R&D) and Commercial Manufacturing. The ideal candidate will have extensive experience in method development, method validation, method transfer, routine microbiological testing, and a strong understanding of cGMP regulations, FDA requirements, USP/EP/JP standards, and aseptic manufacturing environments. This role requires a highly organized and adaptable professional who can manage multiple priorities while ensuring compliance with regulatory standards and supporting product development and manufacturing initiatives.Key ResponsibilitiesDevelop and implement microbiological strategies, procedures, and testing programs to ensure compliance with industry standards and regulatory requirements.Perform microbiological method development, feasibility studies, validation, and method transfer for raw materials, in-process samples, and finished products.Conduct routine microbiological testing and analysis of: Raw Materials, In-Process Samples, Finished Products, Stability Samples, GLP and GMP Materials.Execute microbiological testing in accordance with USP, EP, JP, AAMI, and ISO standards.Develop, revise, and maintain: Standard Operating Procedures (SOPs), Validation Protocols, Validation Reports, Laboratory Documentation.Generate data to support validation studies, product development, and special projects.Recommend, qualify, and validate new laboratory equipment, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).Review, analyze, and interpret microbiological test results and prepare technical reports.Maintain complete and accurate laboratory records in compliance with cGMP and data integrity requirements.Identify opportunities to improve microbiological methods, laboratory processes, and testing efficiency.Collaborate with cross-functional teams including Quality Assurance, Research & Development, Manufacturing, Engineering, Regulatory Affairs.Support investigations related to Deviations, Out-of-Specification (OOS) Results, CAPAs, Change Controls.Ensure laboratory compliance with FDA regulations, GMP requirements, and company quality systems.Stay current with industry trends, regulatory updates, and emerging microbiological technologies.Required QualificationsEducationBachelor's degree in Microbiology, Biology, or a related Life Sciences discipline.ExperienceMinimum 8 years of pharmaceutical, biotechnology, or medical device microbiology experience in a cGMP-regulated environment.Hands-on experience with: Method Development, Method Validation, Method Transfer, Routine Microbiological Testing.Experience supporting both R&D and Commercial Manufacturing environments.Experience with aseptic manufacturing processes and cleanroom operations.Required Technical SkillsMethod DevelopmentMethod ValidationMethod TransferSterility TestingMicrobial EnumerationEnvironmental MonitoringBioburden TestingEndotoxin TestingGram StainingPlating TechniquesAseptic TestingMicrobial IdentificationStandards & RegulationsUSPEPJPAAMI StandardsISO StandardsFDA RegulationsCurrent Good Manufacturing Practices (cGMP)Good Laboratory Practices (GLP)Laboratory EquipmentLaboratory Equipment CalibrationEquipment Qualification (IQ/OQ/PQ)Laboratory Instrument MaintenanceQuality SystemsCAPAChange ControlDeviationsOOS InvestigationsDocumentation PracticesSOP WritingValidation Protocols & ReportsPreferred SkillsStrong understanding of aseptic manufacturing and contamination control.Experience with laboratory investigations and root cause analysis.Strong analytical and troubleshooting skills.Excellent technical writing and documentation skills.Strong organizational and time management skills.Ability to prioritize multiple projects in a fast-paced environment.Excellent communication and cross-functional collaboration skills.Proficiency with Microsoft Office Suite and laboratory software systems Trident Consulting