Microbiologist_2nd Shift (403)
About The Position
The Microbiologist will join Civica at its 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 sampling, helping ensure microbiology laboratory operations and testing comply with applicable regulatory standards, including cGMPs and FDA guidance. The position also supports the generation and review of procedures, reports, and records needed to design, implement, and maintain a microbiology laboratory that meets or exceeds FDA requirements. 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.
- Microbiology testing and environmental monitoring experience.
- 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.
- Self-motivated and flexible, with the ability 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, collaborating to overcome challenges, and focusing on priorities.
- Continuously seeks opportunities to learn, build skills, and share knowledge.
- Ability to lift approximately 40 lbs, stand for 2 to 3 hours at a time, and walk long distances.
- Capability to wear gowning and PPE in the aseptic core and supporting areas for extended periods, including standing, bending, reaching, and kneeling.
- Vision screening may be required.
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.
- A degree in microbiology.
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/non-viable particulate monitoring, and growth promotion studies.
- Qualify laboratory equipment and conduct ongoing maintenance and calibration.
- Establish and coordinate test sampling plans.
- Perform microbiological testing and sample collection for 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 microbiology and environmental monitoring quality risk assessments.
- Proactively 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
