AT02-032426 Validation Specialist

Validation & Engineering Group • Duluth, GA

23h • Onsite

About The Position

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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. Summary: We are seeking a Validation Specialist to support product transfer and validation activities within a regulated manufacturing environment at a client site in Johns Creek, GA. This role will focus on equipment qualification and technical documentation (IOQ/PQ) supporting ongoing manufacturing transfer projects, where timelines, coordination, and execution readiness are critical. The selected candidate must be proactive, detail-oriented, and capable of managing multiple deliverables across parallel workstreams.

Requirements

• Bachelors degree in Engineering or a related scientific discipline preferred.
• Minimum 4 years of experience supporting CQV or validation activities in a GMP-regulated environment.
• Strong experience in technical writing and protocol development (IOQ/PQ focus).
• Experience supporting equipment qualification within product transfer or manufacturing change environments strongly preferred.
• Kneat experience required.
• Strong understanding of cGMP and regulatory expectations.
• Ability to work on-site in a fast-paced, deadline-driven environment.
• Strong organizational, communication, and problem-solving skills.
• Willingness and ability to travel as needed for future project assignments.

Nice To Haves

• Experience in the medical device industry preferred; experience in contact lens manufacturing is highly preferred.

Responsibilities

• Develop, review, and execute validation documentation, including: Risk assessments Commissioning and qualification protocols (IOQ, IQ/OQ/PQ) Summary reports
• Support product transfer activities, ensuring validation deliverables align with project milestones and manufacturing readiness.
• Coordinate closely with stakeholders to support the protocol approval process, addressing comments and driving timely closure.
• Prepare for and support execution activities, including: Verification of prerequisites Staging of documentation and supporting evidence Ensuring readiness for IOQ/PQ execution
• Support equipment, utilities and facilities qualification activities.
• Support deviations, investigations, and documentation updates during execution.
• Collaborate with engineering, quality, manufacturing, and project teams to support aggressive project timelines and multiple concurrent initiatives.
• Ensure all validation deliverables comply with cGMP requirements, FDA regulations, and site procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level