Sr. Microbiologist

Trident Consulting

Aliso Viejo, CA

JOB DETAILS
SKILLS
Analysis Skills, Asepsis, Association for the Advancement of Medical Instrumentation (AAMI), Biology, Biotech and Pharmaceutical, Calibration, Change Control, Cleanroom, Communication Skills, Consulting, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Quality, Documentation, Emerging Technology, Environmental Monitoring, Establish Priorities, FDA Requirements, Feasibility Analysis, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Industry Standards, Industry/Trade Analysis, Laboratory, Laboratory Equipment, Laboratory Systems, Laboratory Testing, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Medical Equipment, Microbiology, Microsoft Office, Multitasking, Operations Processes, Organizational Skills, Plating Processes, Process Validation, Product Development, Product Support, Product Testing, Quality Assurance, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Research & Development (R&D), Root Cause Analysis, Standard Operating Procedures (SOP), Team Player, Technical Writing, Test Program, Testing, Time Management, Validation Plan, Writing Skills
LOCATION
Aliso Viejo, CA
POSTED
1 day ago
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

About the Company

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Trident Consulting