Microbiologist_2nd Shift (403)
About The Position
The Microbiologist will work at Civica’s Petersburg, Virginia site, a fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications. The role supports the establishment and maintenance of the microbiology testing laboratory and facility environmental monitoring program, helping ensure microbiology testing complies with applicable regulatory standards, including current Good Manufacturing Practices and FDA guidance. The position also generates and/or reviews procedures, reports, and records that support the design, implementation, and maintenance of a microbiology laboratory that meets or exceeds FDA requirements. The Microbiologist performs microbiological testing, sampling, equipment qualification and maintenance, and environmental monitoring work. The role also contributes to method verification and transfers, training, investigations, risk assessments, and the resolution of technical issues. Travel may be required.
Requirements
- Bachelor’s degree in a scientific discipline; a microbiology degree is preferred.
- At least 4 years of Quality/cGMP experience in the pharmaceutical industry.
- Experience with microbiology testing and environmental monitoring.
- Participation in activities supporting regulatory agency inspections.
- Strong project management, organization, and execution skills.
- Excellent interpersonal and written communication skills.
- Experience with various software and electronic applications.
- Ability to work in a small, fast-paced, dynamic environment; self-motivated and flexible.
- Ability to work autonomously within established guidelines, procedures, and practices.
- Commitment to delivering high-quality results, collaborating to overcome challenges, focusing on priorities, and continuing to learn, build skills, and share knowledge.
- Ability to lift approximately 40 pounds, stand for 2 to 3 hours at a time, and walk long distances.
- Ability to don gowning/PPE and work in aseptic core and supporting areas for extended periods, including standing, bending, reaching, and kneeling.
- Vision screening may be required; specific vision abilities include color vision, close vision, distance vision, and ability to adjust focus.
Nice To Haves
- Experience in sterile injectable manufacturing, aseptic processing, and facility qualification.
- Experience with sterility testing and method suitability testing per USP <71>.
- Experience with acceptance testing and use of biological indicators.
Responsibilities
- Support the establishment and maintenance of the microbiological testing laboratory in compliance with cGMPs and industry best practices.
- Perform microbiological testing consistent with USP requirements, including bioburden, bacterial endotoxin, microbial isolate and objectionable organism identification, viable and non-viable particulate monitoring, and growth promotion studies.
- Conduct and maintain laboratory equipment qualifications, ongoing maintenance, and calibration.
- Establish and coordinate test sampling plans.
- Perform microbiological testing and sample collection to support environmental monitoring and utilities systems.
- Participate in microbiological method verification and method transfers.
- Participate in developing 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.
- Identify and collaboratively resolve problems using risk-based, compliant approaches.
- Author and/or review SOPs, protocols, reports, test methods, and product specification documents as applicable.
- Promote a quality mindset and quality excellence in all activities.
- Travel as required.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
