What are the responsibilities and job description for the ATL04-012325 Commissioning & Qualification (SME) - GA 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:
- Commissioning & Qualification Subject Matter Expert (SME)
Location: Athens, GA
Position Overview:
We are seeking a Subject Matter Expert (SME) to provide specialized knowledge and support for the decommissioning, relocation, commissioning, and qualification of a new QC laboratory. The SME will bring expertise in laboratory systems, utilities, and regulatory compliance to ensure successful project execution.
Responsibilities:
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Provide technical expertise in laboratory systems and utilities to support C&Q activities.
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Collaborate with project teams to ensure alignment with regulatory standards and industry best practices.
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Conduct risk assessments and develop mitigation strategies for complex technical challenges.
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Review and approve project documentation, including protocols and reports, for accuracy and compliance.
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Serve as a resource for troubleshooting and resolving technical issues during the project lifecycle.
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Provide training and guidance to project team members on specialized topics.
Qualifications:
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Bachelors degree in engineering, life sciences, or a related field.
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Minimum of 5 years of experience as a Subject Matter Expert in pharmaceutical or regulated environments.
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In-depth knowledge of laboratory systems, utilities, and C&Q processes.
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Strong understanding of cGMP, FDA, and industry guidelines.
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Excellent problem-solving, communication, and leadership skills.
