Senior Microbiologist, 2nd Shift — Microbiology Lead

BioSpace; Irvine (CA); On-site; USD 61,000 - 66,000; Full time

Benefits offered by this job

Medical

Dental

Vision

FSA & HSA

Life Insurance

Short/Long Term Disability

Pet Insurance

401K

Job summary

Siegfried is seeking a Senior Microbiologist III for the 2nd shift (2:00 PM – 10:30 PM) to support sterile pharmaceutical manufacturing. You will perform environmental monitoring testing, provide direct microbiology support to aseptic operations, and lead method validation activities while mentoring junior staff.

You will investigate OOS/OOT incidents, author technical reports, and contribute to contamination control, product quality, and patient safety across a growing CDMO.

Qualifications

• Bachelor’s degree in Microbiology or related field (advanced degree preferred).
• 8–10+ years of pharmaceutical microbiology experience in sterile manufacturing.
• Experience executing microbiological method validation and qualification studies.
• Experience providing direct microbiology support to aseptic manufacturing operations.
• Experience leading OOT, OOS, deviation, and microbiology investigations.

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.
• Perform specialized testing, including Antimicrobial Effectiveness Testing (AET).
• Lead method validation and qualification studies, data analysis, and report generation.
• Mentor fellow microbiologists and support regulatory inspections and audits.

Skills

Microbiology expertise

Aseptic processing

Environmental monitoring

Technical writing

Leadership experience

Education

Bachelor’s degree in Microbiology (related)

Tools

LIMS

Job description

Siegfried is seeking a Senior Microbiologist III for the 2nd shift (2:00 PM – 10:30 PM) to support sterile pharmaceutical manufacturing. You will perform environmental monitoring testing, provide direct microbiology support to aseptic operations, and lead method validation activities while mentoring junior staff.

You will investigate OOS/OOT incidents, author technical reports, and contribute to contamination control, product quality, and patient safety across a growing CDMO.