Principal Engineer job in Athens, GA
Athens, GA CorTech LLC
| Job Ref: | 375876 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | Market/Per Hour |
| Remote: | No |
Location |
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| City: | Athens, GA |
| Post Code: | 30601 |
| Map: |
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Description |
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Position Summary: The Principal Commissioning/Validation Engineer I will support commissioning and validation activities within a pharmaceutical manufacturing environment, with a focus on aseptic processing, sterilization, equipment requalification, and regulatory compliance. This role will develop and execute validation protocols, support audits, CAPAs, deviations, and change controls, and provide technical expertise across Engineering, Maintenance, and Production. Key Responsibilities: Perform smoke studies and support semi-annual media fill qualifications as a subject matter expert. Conduct requalification and periodic reviews of autoclaves, dehydrogenations tunnels, cold rooms, freezers, and warehouse areas. Utilize Ellab data loggers and software for validation activities. Write and execute protocols and prepare final validation reports. Apply cleaning validation concepts and principles. Support validation of pharmaceutical-grade utilities, including water, HVAC, and gases. Develop and support URS, RA, FRS, and DQ documentation for systems and production equipment. Support equipment selection, acquisition, upgrades, and technical reviews. Assist with audit responses and CAPA completion while maintaining validation areas in an inspection-ready state. Support Change Control, Deviation, and CAPA activities. Required Skills: Aseptic processing Protocol generation Sterilization Commissioning/Validation FDA/USDA regulatory environment Equipment and systems validation Strong technical documentation and communication skills Education: Bachelor?s degree preferred, ideally in a science or engineering-related field. | |
ref: (375876)
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