ATLValidation Specialist – Laboratory CQV & Method Validation - GA

ATL
01-092425 Validation Specialist – Laboratory CQV & Method Validation - GA

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other technical services.

We are seeking a skilled Validation Engineer to support a critical project at a manufacturing facility in Johns Creek, GA. The consultant will focus on laboratory equipment qualifications and analytical method validations to enable implementation of new products in production. This is a client-facing, hands-on role requiring strong technical expertise, attention to detail, and ability to work independently.

Location: Johns Creek, GA

Duration: October 20, 2025 – January 9, 2026

Commitment: Full-time (40–45 hours/week)

• Plan, author, and execute qualification protocols (IQ/OQ/PQ) for new laboratory instruments, including Tru Scans and balances.
• Develop and execute validation protocols for ~11 analytical methods (e.g., Gas Chromatography, UV-Vis Spectroscopy, Karl Fischer Titrations).
• Generate and revise validation documentation (protocols, reports, SOPs, specifications) in compliance with cGMP standards.
• Conduct investigations for deviations, perform root cause analysis, and implement corrective actions.
• Ensure compliance with Good Documentation Practices (GDP) and “right the first time” deliverables.
• Collaborate with cross-functional teams (QA, Engineering, Production) and communicate project status to stakeholders.
• Support change control management and risk assessment activities.

• Bachelor’s degree in Engineering, Chemistry, or related field.
• 5–7 years of hands-on validation experience in pharmaceutical or medical device industries.
• Proven expertise in laboratory equipment qualification and method validation.
• Experience working with Kneat validation lifecycle management system (authoring, reviewing, approving, and archiving documents).
• Familiarity with risk-based approaches to commissioning and qualification.
• Strong technical writing, communication, and problem-solving skills.
• Proficiency with Microsoft Word, Excel, and Project.
• Ability to work independently and meet strict timelines.

• Experience in computerized system validation (PLC, HMI).
• Knowledge of medical device manufacturing (Class II preferred).
• Prior experience with contact lens production platforms.

• Position requires onsite presence in Johns Creek, GA.
• Contractor must complete required onboarding and training prior to project start.