Microbiologist III - 2nd Shift (Pharmaceutical Microbiology)

Location: Irvine, California, United States; onsite, 2nd shift from 2:00 PM to 10:30 PM, Monday through Friday

Salary: $44–$48 per hour plus a 10% shift differential

Company

Developing and manufacturing APIs and finished dosage forms for pharmaceutical customers as a fully integrated CDMO with 16 sites across three continents and more than 4,200 employees.

What you will do

• Perform microbiological testing of environmental monitoring samples, utilities, raw materials, in-process samples, and finished drug products.
• Provide microbiology support for sterile and aseptic manufacturing operations.
• Execute antimicrobial effectiveness testing, microbiological method validation, and qualification studies.
• Lead OOT, OOS, deviation, and contamination control investigations; analyze data and identify trends.
• Author and review technical protocols, reports, investigations, and scientific documentation.
• Support new product introductions, process improvements, technology transfers, regulatory inspections, and team mentoring.

Requirements

• Bachelor’s degree in Microbiology or a closely related scientific discipline; an advanced degree is preferred.
• 8–10+ years of pharmaceutical microbiology experience supporting sterile manufacturing operations.
• Experience with microbiological method validation and qualification, aseptic manufacturing support, and Antimicrobial Effectiveness Testing.
• Experience leading OOT, OOS, deviation, and microbiology investigations.
• Strong knowledge of aseptic processing, contamination control, environmental monitoring, and cGMP requirements.
• Strong technical writing skills, plus experience with pharmaceutical CDMO environments, regulatory inspections, USP microbiology requirements, LIMS, or mentoring microbiologists.

Culture & Benefits

• Hands-on technical role with opportunities to develop leadership expertise and mentor other microbiologists.
• Medical, dental, and vision insurance.
• Flexible Spending Account and HSA options.
• Life insurance, short- and long-term disability coverage, and pet insurance.
• 401(k) plan.