ATL01-011326 Validation Specialist GA
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Job Location:
Duluth, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group (VEG) is a specialized consulting firm providing Commissioning Qualification and Validation (CQV) services to FDA-regulated industries including pharmaceutical medical device and biotech manufacturing. VEG supports clients with hands-on technical execution regulatory compliance and high-quality documentation with a strong focus on automation packaging and computerized systems.
Position Summary
VEG is seeking a Senior Validation Consultant to support the validation of a Smart Automated Line Clearance system at a regulated manufacturing site. This role will lead validation document development and execution activities working closely with Quality Engineering Automation and Production teams.
This is a hands-on role requiring strong technical writing skills independent execution capability and experience validating automated and computerized systems in a cGMP medical device or pharmaceutical environment.
Key Responsibilities
Author and execute validation documentation for a Smart Automated Line Clearance system
Develop and support the following deliverables:
Validation Plan
Qualification Needs Assessment
URRA / TMX
Functional Design Specification
Configuration Specification
IOQ
Validation Summary Report (VSR)
Generate and update applicable SOPs
Support deviation investigations including root cause and impact analysis
Participate in risk assessments and mitigation strategies
Serve as liaison between QA Engineering Automation and Production
Support validation activities related to computerized systems (PLC HMI) and data integrity requirements (21 CFR Part 11 as applicable)
Track project progress against schedule and provide routine status updates
Required Qualifications
Bachelors degree in Engineering or related technical discipline (Mechanical Electrical Chemical Computer Science or similar)
Minimum 57 years of hands-on validation experience including protocol authoring and execution
Experience validating automated equipment and manufacturing systems
Solid understanding of mechanical and electrical requirements for automated equipment
Experience with Computerized System Validation (PLC HMI)
Strong knowledge of cGMP requirements and Good Documentation Practices
Ability to work independently with minimal supervision
Strong technical writing and communication skills
Proficiency in Microsoft Word Excel and Project
Preferred Experience
Medical device manufacturing experience (Class II preferred)
Risk-based approach to commissioning and qualification
Experience supporting cleaning validation activities
Project engineering or project management experience in cross-functional environments
Required Experience:
IC
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
