What are the responsibilities and job description for the ATL01-032525 Validation Specialist Temperature Mapping & Equipment Qualification - SC position at Validation & Engineering Group?
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Specialist - Temperature Mapping & Equipment Qualification
Job Description:
We are seeking an experienced Validation Specialist to perform temperature mapping and equipment qualifications for various systems at an FDA-regulated production site. The systems include, but are not limited to, incubators, trailers, cold rooms, and others. The selected candidate must also be able to support autoclave qualifications independently, with minimal guidance.
Key Responsibilities:
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Plan, develop, and execute temperature mapping protocols (IQ, OQ, PQ) across a variety of equipment and storage environments.
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Conduct validation studies for systems including incubators, trailers, cold rooms, and others as assigned.
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Perform qualifications using autoclaves independently, including cycle development, validation, and documentation.
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Generate and finalize validation protocols, summary reports, and supporting documentation.
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Ensure all activities are performed in compliance with GMP and applicable FDA regulatory requirements.
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Use Kneat software for protocol execution and documentation (required).
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Collaborate with client teams to meet established project milestones and timelines.
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Provide support and training on client SOPs and validation protocols as needed.
Qualifications:
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Bachelors degree in Engineering, Life Sciences, or a related field.
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Minimum of 3 years of validation experience in GMP-regulated environments.
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Hands-on experience in temperature mapping and environmental monitoring.
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Proven ability to perform autoclave qualifications with minimal supervision.
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Proficiency with Kneat software.
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Strong knowledge of FDA regulations and GMP standards.
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Ability to manage multiple assignments and work independently to meet deadlines.
