ATL04-012325 Commissioning & Qualification (SME) - GA

Job DescriptionJob Description

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:

1. Provide technical expertise in laboratory systems and utilities to support C&Q activities.

2. Collaborate with project teams to ensure alignment with regulatory standards and industry best practices.

3. Conduct risk assessments and develop mitigation strategies for complex technical challenges.

4. Review and approve project documentation, including protocols and reports, for accuracy and compliance.

5. Serve as a resource for troubleshooting and resolving technical issues during the project lifecycle.

6. Provide training and guidance to project team members on specialized topics.

Qualifications:

• Bachelor’s degree in engineering, life sciences, or a related field.

• Minimum of 5 years of experience as a Subject Matter Expert in pharmaceutical or regulated environments.

• In-depth knowledge of laboratory systems, utilities, and C&Q processes.

• Strong understanding of cGMP, FDA, and industry guidelines.

• Excellent problem-solving, communication, and leadership skills.