Job Details

Job Description

Position Overview

The Validation Engineer will provide hands-on validation expertise across equipment and software development projects, ensuring compliance with cGxP and quality standards throughout the full validation lifecycle. This role works closely with internal teams and customers to plan, execute, and document validation activities from design through operation.

Responsibilities

• Provide validation expertise and guidance during:
  
  • Equipment design
  • Software design
  • Build, debug, and qualification phases
• Develop and maintain overall project validation scope and quality plans
• Organize, guide, and author:
  
  • Requirements specifications
  • Qualification plans and protocols
  • Validation documentation as needed
• Review qualification and requalification packages for:
  
  • Completeness and accuracy
  • Sound technical rationale
  • Compliance with internal validation policies
• Interface with internal teams and client validation/engineering teams to secure document approvals
• Oversee and execute validation qualifications:
  
  • At company facilities
  • At customer sites
• Ensure validation documentation is completed on schedule to meet project timelines
• Author validation summary reports
• Support validation deviations, change requests, and identify qualification requirements to maintain systems in a validated state
• Ensure compliance with all applicable cGxP requirements
• Promote a strong quality mindset across:
  
  • Equipment design
  • Software development
  • Change control
  • Documentation practices
• Support all phases of the Validation Lifecycle, from design through operational improvement
• Develop and customize validation document templates aligned with customer SOPs

• 3+ years of experience performing validation activities
• Experience with:
  
  • Custom engineered solutions
  • Medical Devices and/or Life Sciences environments (preferred)
• Experience working with electrical design drawings
• Familiarity with GAMP 5-based validation models
• Experience debugging and working with custom machines (preferred)
• Experience with Rockwell Automation PLC Control Systems (preferred)

• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Strong documentation and validation reporting skills

• Excellent presentation and communication skills
• Ability to mentor and guide teams without direct authority
• Strong team collaboration skills
• Self-starter with the ability to work independently with minimal supervision

• Bachelor of Science (B.S.) degree in one of the following or equivalent experience:
  
  • Systems Engineering
  • Life Sciences
  • Electrical / Controls Engineering
  • Quality Assurance
  • Related technical discipline