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Sr. Microbiologist

Trident Consulting
  • Aliso Viejo, CA
  • Quick Apply
30+ days ago

Job Description

Trident Consultant is hiring for a "Senior Microbiologist” role in "Aliso Viejo, CA (Onsite)” with one of our industry-leading clients

Job Title: Senior Microbiologist
Location: Aliso Viejo CA
Employment Type: Contract

Position Overview
We 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 Responsibilities
  • Develop 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 Qualifications
Education
  • Bachelor's degree in Microbiology, Biology, or a related Life Sciences discipline.
Experience
  • Minimum 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 Skills
Microbiology
  • Method Development
  • Method Validation
  • Method Transfer
  • Sterility Testing
  • Microbial Enumeration
  • Environmental Monitoring
  • Bioburden Testing
  • Endotoxin Testing
  • Gram Staining
  • Plating Techniques
  • Aseptic Testing
  • Microbial Identification
Standards & Regulations
  • USP
  • EP
  • JP
  • AAMI Standards
  • ISO Standards
  • FDA Regulations
  • Current Good Manufacturing Practices (cGMP)
  • Good Laboratory Practices (GLP)
Laboratory Equipment
  • Laboratory Equipment Calibration
  • Equipment Qualification (IQ/OQ/PQ)
  • Laboratory Instrument Maintenance
Quality Systems
  • CAPA
  • Change Control
  • Deviations
  • OOS Investigations
  • Documentation Practices
  • SOP Writing
  • Validation Protocols & Reports
Preferred Skills
  • Strong 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

Numbers & Facts

LocationAliso Viejo, CA

Skills

  • Analysis Skillsunmatched
  • Asepsisunmatched
  • Association for the Advancement of Medical Instrumentation (AAMI)unmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Calibrationunmatched
  • Change Controlunmatched
  • Cleanroomunmatched
  • Communication Skillsunmatched
  • Consultingunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Data Qualityunmatched
  • Documentationunmatched
  • Emerging Technologyunmatched
  • Environmental Monitoringunmatched
  • Establish Prioritiesunmatched
  • FDA Requirementsunmatched
  • Feasibility Analysisunmatched
  • GLP (Good Laboratory Practices)unmatched
  • GMP (Good Manufacturing Practices)unmatched
  • ISO (International Organization for Standardization)unmatched
  • Identify Issuesunmatched
  • Industry Standardsunmatched
  • Industry/Trade Analysisunmatched
  • Laboratoryunmatched
  • Laboratory Equipmentunmatched
  • Laboratory Systemsunmatched
  • Laboratory Testingunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing/Industrial Processesunmatched
  • Medical Equipmentunmatched
  • Microbiologyunmatched
  • Microsoft Officeunmatched
  • Multitaskingunmatched
  • Operations Processesunmatched
  • Organizational Skillsunmatched
  • Plating Processesunmatched
  • Process Validationunmatched
  • Product Developmentunmatched
  • Product Supportunmatched
  • Product Testingunmatched
  • Quality Assuranceunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Reporting Skillsunmatched
  • Research & Development (R&D)unmatched
  • Root Cause Analysisunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Team Playerunmatched
  • Technical Writingunmatched
  • Test Programunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Validation Planunmatched
  • Writing Skillsunmatched

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