Pharmaceutical Microbiologist II

Trident Consulting is seeking a "
Microbiologist II " for one of our client in "
Aliso Viejo, CA A global leader in business and technology services.

We are seeking an experienced Microbiologist II with 5–8 years of pharmaceutical microbiology experience in a cGMP-regulated environment
. The ideal candidate will perform routine microbiological testing, support method development and validation, maintain regulatory compliance, and collaborate with Quality, Manufacturing, Engineering, and R&D teams.

Experience with
USP microbiological testing, aseptic manufacturing, FDA regulations, and validation activities is required.

• Perform routine microbiological testing of raw materials, in-process, finished products, and stability samples
  .
• Conduct microbial enumeration, sterility, bioburden, bacterial endotoxin (BET), antimicrobial effectiveness (USP ), and growth promotion testing
  .
• Prepare microbiological media, reagents, and maintain laboratory inventory and supplies.
• Operate, calibrate, maintain, and troubleshoot laboratory equipment.
• Document test results in compliance with cGMP, GDP, and GLP requirements.
• Review microbiological data and investigate OOS, OOT, deviations, and CAPAs
  .
• Support method development, method validation, method verification, and method transfer activities.
• Assist with IQ/OQ/PQ qualification of laboratory equipment.
• Prepare and revise SOPs, validation protocols, and technical reports.
• Perform microbiological trend analysis and recommend process improvements.
• Support internal/external audits and FDA inspections.
• Collaborate with cross-functional teams including Quality Assurance, Manufacturing, Engineering, and R&D.
• Train and mentor junior laboratory personnel.

• Pharmaceutical microbiology experience in a cGMP environment
  .
• Strong knowledge of USP , , , , , AAMI, ISO, and FDA regulations.
• Hands-on experience with:
• Sterility Testing
• Bacterial Endotoxin Testing (BET)
• Microbial Enumeration
• Growth Promotion Testing
• Antimicrobial Effectiveness Testing
• Experience with aseptic processing and sterile manufacturing
  .
• Knowledge of GLP, GDP, SOPs, Change Control, Deviations, CAPA, and Quality Systems
  .
• Experience supporting method validation, transfer, verification, and laboratory investigations
  .
• Strong documentation, analytical, troubleshooting, and communication skills.
• Proficiency with Microsoft Office and laboratory documentation systems.

• Bachelor's degree in Microbiology, Biology, or related Life Science
  .
• 5–8 years of pharmaceutical microbiology experience in a cGMP-regulated environment
  .
• Experience supporting FDA-regulated manufacturing and laboratory operations.

• Method development and validation.
• Stability studies and microbiological trend analysis.
• Supporting regulatory audits and inspections.
• Training and mentoring laboratory staff.
• Ability to work in a sterile manufacturing environment while wearing appropriate PPE and gowning.
• Ability to lift up to 25 lbs
  .
• Ability to stand or sit for extended periods (8+ hours).

Trident Consulting is an award-winning staffing and consulting firm headquartered in San Ramon, CA. Since 2005, we’ve partnered with Fortune 500 and high-growth companies to deliver high-quality talent across technology, engineering, business operations, and professional services.

We specialize in contract, contract-to-hire, and direct hire placements, supporting roles across IT, data & analytics, cloud, cybersecurity, finance & accounting, HR, operations, and more. With a strong focus on hard-to-fill and niche positions, our global recruiting engine enables us to deliver speed, quality, and scale.