Senior Microbiologist, Sterile Injectables QC

Civica, Inc.; Petersburg (VA); On-site; USD 80,000 - 110,000; Full time

Job summary

The Microbiology position at Civica, Inc. in Petersburg, Virginia supports the establishment and maintenance of the microbiology testing laboratory and environmental monitoring for a new fill-finish facility dedicated to sterile injectable medicines.

The role ensures cGMP compliance, FDA guidance alignment, and the preparation of procedures, reports, and records to support lab operations and regulatory readiness.

Qualifications

• Bachelor’s degree in a scientific discipline with 4+ years of QA/cGMP experience in the pharmaceutical industry.
• Strong project management, organization, and execution skills.
• Microbiology testing and environmental monitoring experience.
• Experience supporting regulatory agency inspections is required.
• Excellent interpersonal and written communication skills, and experience with various software/electronic applications, are required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.

Responsibilities

• Support the establishment and maintenance of the microbiological testing laboratory to ensure compliance with cGMPs and industry standards for best practices.
• Perform microbiological testing methods consistent with USP testing requirements, including bioburden, endotoxin, identification of isolates, EM and growth promotion studies.
• Conduct and maintain qualifications and calibration of laboratory equipment.
• Establish and coordinate test sampling plans and EM support.
• Lead investigations related to laboratory operations and non-conforming results.
• Author/review SOPs, protocols, and test methods.
• Travel may be required.

Skills

Microbiology testing

Environmental monitoring

cGMP

SOP development

Regulatory inspections

Project management

Documentation

Education

Bachelor's degree in science

Microbiology degree preferred

Job description

The Microbiology position at Civica, Inc. in Petersburg, Virginia supports the establishment and maintenance of the microbiology testing laboratory and environmental monitoring for a new fill-finish facility dedicated to sterile injectable medicines.

The role ensures cGMP compliance, FDA guidance alignment, and the preparation of procedures, reports, and records to support lab operations and regulatory readiness.