Civica Rx · 1 month ago
Microbiologist – (353)
Petersburg, VA
Full-time
Onsite
Mid Level
4+ years expCivica Rx is a nonprofit organization focused on preventing drug shortages in U.S. healthcare. The Microbiologist will be responsible for supporting facility qualification and equipment validation at the Petersburg, Virginia site, ensuring compliance with regulatory standards for the microbiology laboratory and testing.
Pharmaceutical
Responsibilities
Support establishing and maintaining 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 but not limited to the following microbiological testing and procedures: bioburden, bacterial endotoxin, identification of microbial isolates and objectional organisms, viable/non-viable particulate monitoring, and growth promotion studies
Conduct and maintain qualifications of laboratory equipment as well as ongoing maintenance and calibration
Establish and coordinate test sampling plans
Perform microbiological testing and sample collection to support environmental monitoring (EM) and utility systems
Author and participate in the verification of microbiological methods and method transfers
Participate in the development of training programs for microbiologists
Lead and/or participate in investigations related to laboratory operations and non-conforming results
Identify, track, and facilitate resolution of technical issues
Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions
Author and/or review SOPs, protocols, reports, test methods, and product specification documents as applicable
Create and/or revise Risk Assessments
Promote a quality mindset and quality excellence approach to all activities
Travel (up to 10%) may be required
Qualification
Required
Bachelor's degree in a scientific discipline (microbiology degree preferred) with a minimum of 4 years of Quality/cGMP experience in the pharmaceutical industry
Strong project management, organization, and execution skills
Microbiology testing and environmental monitoring experience
Participation in activities to support regulatory agency inspections required
Excellent interpersonal and written communication skills and experience using various software/electronic applications 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
Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters
Continuously look for opportunities to learn, build skills and share knowledge with others
Preferred
Experience in sterile injectable manufacturing, aseptic processing, and facility qualification
Environmental monitoring in isolators and cleanrooms per Annex 1 requirements
Experience with the following microbiological testing and procedures
Sterility testing and method suitability testing per USP
Acceptance testing and use of biological indicators
Company
Civica Rx
Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.
51-200 employees
H1B Sponsorship
Civica Rx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (2)
2022 (1)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$3M2025-08-07Grant· $3M
Leadership Team
Ned McCoy
CEO
Dave Sehgal
Chief Manufacturing and Supply Chain Officer
Recent News
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