Sr. Microbiologist

Perform microbiological method development, feasibility studies, validation, and method transfer for raw materials, in-process samples, and finished products. We are seeking an experienced Senior Microbiologist to support microbiological activities across Research & Development (R&D) and Commercial Manufacturing.

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