Associate Microbiologist (216)

About the role

The Associate Microbiologist will join the Civica team at the Petersburg, Virginia site, contributing expertise to support patients and uphold excellence in quality and compliance. This role is critical to establishing and maintaining the microbiology testing laboratory and facility environmental monitoring at Civica’s new fill-finish facility, dedicated to manufacturing essential generic sterile injectable medications.

Responsibilities

• Perform microbiological testing methods consistent with USP testing requirements, including but not limited to:
  • Bioburden testing
  • Bacterial endotoxin testing
  • Identification of microbial isolates
  • Viable/non-viable particulate monitoring
  • Growth promotion studies
• Maintain laboratory equipment, including ongoing maintenance and calibration.
• Execute test sampling plans and perform microbiological testing and sample collection for environmental monitoring (EM) and utilities systems.
• Participate in verification of microbiological methods and method transfers.
• Support investigations related to laboratory operations and non-conforming results.
• Identify, track, and facilitate resolution of technical issues.
• Participate in risk assessments related to microbiology and environmental monitoring.
• Proactively identify and resolve problems using risk-based and compliant approaches.
• Author and/or review SOPs, protocols, reports, test methods, and product specification documents.
• Promote a quality mindset and excellence in all activities.
• Travel may be required.

Requirements

• Bachelor’s degree in a scientific discipline (microbiology degree preferred).
• Minimum of 2 years of Quality/cGMP experience in the pharmaceutical industry.
• Experience with microbiology testing and environmental monitoring.
• Participation in activities to support regulatory agency inspections.
• Strong organizational and execution skills.
• Excellent interpersonal and written communication skills.
• Proficiency with various software/electronic applications.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Ability to work autonomously within established guidelines, procedures, and practices.
• Commitment to delivering high-quality results and collaborating to overcome challenges.
• Continuous learning mindset with a focus on skill-building and knowledge-sharing.

Preferred Qualifications

• Experience in sterile injectable manufacturing, aseptic processing, and facility qualification.
• Experience with the following microbiological testing and procedures:
  • Acceptance testing and use of biological indicators

Physical Demands and Work Environment

• Regularly required to speak or hear.
• Frequently required to use hands or fingers to handle or feel objects, tools, or controls.
• Occasionally required to stand, walk, sit, and reach with hands and arms.
• Specific vision abilities required include color vision, close vision, distance vision, and the ability to adjust focus.
• Noise level in the work environment is usually low to moderate.
• Ability to lift approximately 40 lbs.
• Ability to stand for 2 to 3 hours at a time and walk long distances.
• Vision screening may be required.
• Must be able to don gowning/PPE for entry into the aseptic core and supporting areas for extended periods, including standing, bending, reaching, and kneeling.