Microbiologist - 3rd Shift (#399)

Civica • Petersburg, VA

425d

About The Position

The Microbiologist 3rd Shift position at Civica involves joining a newly established team at the Petersburg, Virginia site, focusing on ensuring compliance with regulatory standards in the microbiology laboratory. The role is critical for supporting facility qualification and equipment validation, contributing to the reliable supply of essential generic sterile injectable medications.

Requirements

• Bachelor's degree in a scientific discipline (microbiology degree preferred) with a minimum of 8+ 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 is 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 looking for opportunities to learn, build skills, and share knowledge with others.

Nice To Haves

• Experience in sterile injectable manufacturing, aseptic processing, and facility qualification.
• Environmental monitoring per Annex 1 requirements.
• Experience with sterility testing and method suitability testing per USP.
• Acceptance testing and use of biological indicators.

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 bioburden, bacterial endotoxin, identification of microbial isolates, viable/non-viable particulate monitoring, and growth promotion studies.
• Conduct and maintain qualifications for laboratory equipment and ongoing maintenance and calibration.
• Establish and coordinate test sampling plans.
• Perform microbiological testing and sample collection to support environmental monitoring (EM) and utilities systems.
• Participate in 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.
• Promote a quality mindset and quality excellence approach to all activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees