ATL01-092425 Validation Specialist - Laboratory CQV & Method Validation - GA

Job Description

Job Description

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.

• Validation Engineer – Laboratory & Method Validation

Location: Johns Creek, GA
Duration: October 20, 2025 – January 9, 2026
Commitment: Full-time (40–45 hours/week)

Position Overview
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.

Key Responsibilities

• Plan, author, and execute qualification protocols (IQ/OQ/PQ) for new laboratory instruments, including TruScans 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.

Required Qualifications

• 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.

Preferred Qualifications

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

Additional Information

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