Job Description

The Microbiologist will join the Civica organization at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. Responsibilities of the position include supporting the establishment and maintenance of the microbiology testing laboratory and facility environmental monitoring sampling.

The role is essential to ensure the Petersburg site’s microbiology laboratory and testing comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, and FDA Guidance documents) and expectations for the development and reliable supply of quality medicines. Responsibilities also include, but are not limited to, the generation and/or review of procedures, reports, and other records necessary to support the design, implementation, and maintenance of a microbiology laboratory that meets or exceeds FDA requirements.

Essential Duties and 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 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 the 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 utilities systems.

·      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.

·      Conduct quality risk assessments related to microbiology and environmental monitoring.

·      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.

·      Travel may be required.

Basic Qualifications and Capabilities:

·      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 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.

·      Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.

·      Continuously seeks opportunities to learn, build skills, and share knowledge with others.

Preferred Qualifications:

Experience in sterile injectable manufacturing, aseptic processing, and facility qualification.

Experience with the following microbiological testing and procedures:

·      Sterility testing and method suitability testing per USP <71>

·      Acceptance testing and use of biological indicators

Physical Demands and Work Environment:

The physical demands described here are representative of those required of an employee to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms.