Validation Engineer Validation Engineer

Validation Engineer
Location: Liberty / Greenville, SC

We are seeking a Validation Engineer to support increased medical manufacturing project work at a custom automation facility in Liberty, SC. This role will focus on executing validation and qualification activities for custom-engineered automation systems supporting medical, life sciences, pharmaceutical, process, and related manufacturing customers.

This person will work closely with engineering, controls, project teams, and customer validation groups to execute test scripts, support commissioning and qualification, review validation documentation, and ensure equipment and software validation activities meet project and customer requirements.

Responsibilities

• Execute validation and qualification activities within a GAMP 5-based validation model
• Support commissioning and qualification of custom-engineered automation equipment
• Execute approved test scripts and assist with IQ/OQ documentation
• Review electrical design drawings and support validation documentation accuracy
• Assist with debugging and troubleshooting custom machines during commissioning
• Develop or support validation documentation including requirement specifications, qualification protocols, validation plans, and summary reports
• Review qualification/requalification packages for completeness, accuracy, rationale, and compliance
• Interface with internal teams and customer validation/engineering teams to secure documentation approvals
• Communicate validation progress, risks, and issues to project stakeholders
• Support validation lifecycle activities from design through operation and improvement
• Mentor and guide project team members through validation activities without direct authority

Requirements

• Bachelors degree in Systems Engineering, Life Sciences, Electrical Engineering, Controls Engineering, Quality Assurance, or a related technical discipline
• 3+ years of validation experience
• Experience in process, regulated, or validation-driven manufacturing environments
• Strong documentation, organization, and communication skills
• Ability to work independently with minimal guidance
• Proficiency with Microsoft Office
• Experience working in cross-functional engineering or project teams

Preferred Experience

• Custom-engineered automation systems
• Medical device, life sciences, pharmaceutical, food, or regulated manufacturing
• IQ/OQ/DQ documentation
• GAMP 5 validation model
• Packaging systems and/or vision systems
• Rockwell Automation PLC systems
• Commissioning and qualifying multiple pieces of equipment
• Hands-on custom machine build, debug, or troubleshooting experience