ATL01-092425 Validation Specialist Laboratory CQV & Method Validation GA
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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.
Required Experience:
Unclear Seniority
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
