What are the responsibilities and job description for the ATL01-092425 Validation Specialist Laboratory CQV & Method Validation - GA position at Validation & Engineering Group?
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 (4045 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
- Bachelors degree in Engineering, Chemistry, or related field.
- 57 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.
