Jobs · Analyst · California

Microbiologist III - 2nd Shift

BioSpace · Irvine, CA · 1 mo ago
Analyst$44–$48/hrFull-time

About the role

At Siegfried, you’ll find exciting challenges and ample opportunities to showcase your talents while working for a trusted partner to the pharmaceutical industry. The company upholds the highest standards in safety, quality, and sustainability, fostering a collaborative environment where diverse perspectives thrive. As a Microbiologist III on the 2nd Shift (2 PM – 10:30 PM), you will support sterile manufacturing operations within a growing pharmaceutical CDMO, remain hands‑on in the laboratory, and expand your expertise in microbiological investigations, technical writing, method verification, and programs that ensure product quality, contamination control, and patient safety.

Responsibilities

  • Perform microbiological testing of environmental monitoring samples, utilities, raw materials, in‑process samples, and finished drug products.
  • Provide direct microbiology support for sterile and aseptic manufacturing operations.
  • Conduct specialized testing, including Antimicrobial Effectiveness Testing (AET).
  • Execute microbiological method validation and qualification studies, including protocol execution, data analysis, and report generation.
  • Lead out‑of‑trend (OOT), out‑of‑specification (OOS), deviation, and contamination control investigations.
  • Evaluate microbiological and environmental monitoring data to identify trends and support scientific decision‑making.
  • Author and review technical protocols, reports, investigations, and other scientific documentation.
  • Support new product introductions, process improvements, technology transfers, and regulatory inspections.
  • Mentor fellow microbiologists and help strengthen technical capabilities across the team.

Requirements

  • Required Qualifications
    • Bachelor’s degree in Microbiology or a closely related scientific discipline (advanced degree preferred).
    • 8–10+ years of pharmaceutical microbiology experience supporting sterile manufacturing operations.
    • Experience executing microbiological method validation and qualification studies.
    • Experience providing direct microbiology support to aseptic manufacturing operations.
    • Experience supporting Antimicrobial Effectiveness Testing (AET).
    • Experience leading OOT, OOS, deviation, and microbiology investigations.
    • Strong knowledge of aseptic processing, contamination control, environmental monitoring, and cGMP requirements.
    • Strong technical writing skills with experience authoring protocols, reports, investigations, and scientific documentation.
  • Preferred Qualifications
    • Experience working in a pharmaceutical CDMO environment.
    • Experience supporting regulatory inspections and customer audits.
    • Familiarity with USP microbiology requirements.
    • Experience with LIMS and other electronic laboratory systems.
    • Experience mentoring or providing technical guidance to other microbiologists.

Benefits

  • Medical, Dental, Vision coverage
  • Flexible Spending & HSA options
  • Life Insurance, Short & Long Term Disability
  • Pet Insurance
  • 401(k) retirement plan

Pay

Target Pay Range: $44‑$48 per hour + 10% shift differential. Individual compensation packages are based on factors such as skill set, experience, qualifications, and other job‑related reasons.

Schedule

2nd Shift: 2:00 PM – 10:30 PM, Monday through Friday.

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