Validation Engineer

GForce Life Sciences; Phoenix (AZ); Hybrid; USD 55,000 - 96,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k options

Job summary

A leading organization in medical technology is seeking a Validation Engineer to support a new manufacturing line in Greater Phoenix. The role involves leading validation activities, drafting necessary documentation, and ensuring compliance with medical regulatory standards. Ideal candidates should possess at least 3 years of experience in Validation Engineering, strong technical writing skills, and a background in the medical device industry. This is a hybrid position with benefits including medical, dental, and 401k options.

Qualifications

• 3+ years of Validation Engineering experience.
• Experience drafting validation protocols and managing technical documentation.
• Medical device industry experience required.
• Hands-on experience executing IQ/OQ/PQ validations.
• Strong understanding of validation lifecycle and regulatory documentation.
• Ability to work cross-functionally with engineering, manufacturing, and quality teams.

Responsibilities

• Lead validation activities for new manufacturing equipment.
• Support equipment installation and startup.
• Develop and execute validation strategies including IQ/OQ/PQ.
• Perform product and process validations for medical devices.
• Draft validation protocols, reports, and documentation.
• Collaborate cross-functionally with engineering, quality, and manufacturing teams.
• Draft validation protocols, reports, and supporting documentation.
• Manage documentation through internal document management systems.
• Ensure validation documentation meets regulatory and quality requirements.
• Maintain clear, compliant documentation throughout the validation lifecycle.

Skills

Validation Engineering

Technical Writing

Cross-functional Collaboration

Regulatory Compliance

Tools

ValGenesis

Job description

Consultant, Validation Engineer, Medical Devices

Summary

Our client, a leader in medical device reprocessing, has engaged GForce Life Sciences to provide a Validation Engineer with strong technical writing experience to support a new manufacturing line being installed in Tempe. This role is open due to continued growth in the client’s business. This engineer will play a key role in supporting a manufacturing transfer and new production line launch, ensuring all equipment and processes are properly validated and documented in accordance with medical device regulatory standards.

Responsibilities

• Lead validation activities for new manufacturing equipment and processes supporting the new production line
• Support equipment installation and startup for the new manufacturing line
• Develop and execute validation strategies including IQ/OQ/PQ
• Perform product and process validations for reprocessed medical devices
• Identify equipment requirements and ensure validation readiness for new manufacturing processes
• Collaborate cross-functionally with engineering, quality, and manufacturing teams
• Draft validation protocols, reports, and supporting documentation
• Manage documentation through internal document management systems
• Ensure validation documentation meets regulatory and quality requirements
• Maintain clear, compliant documentation throughout the validation lifecycle

Requirements

• 3+ years of Validation Engineering experience
• Experience drafting validation protocols, reports, and managing technical documentation
• Medical device industry experience required
• Hands-on experience executing IQ/OQ/PQ validations
• Strong understanding of validation lifecycle and regulatory documentation
• Ability to work cross-functionally with engineering, manufacturing, and quality teams

Nice to Have

• Experience using ValGenesis validation lifecycle management software
• Prior experience with reprocessed medical devices or sustainability-focused healthcare technologies
• Experience supporting manufacturing transfers or new line installations

Terms & Start

• Hybrid in Greater Phoenix; 3 days onsite
• 6+ month contract
• Start ASAP
• Benefits included (Medical, Dental, Vision, 401k options)