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)
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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)
#J-18808-Ljbffr
Validation Engineer in phoenix at Unknown Company
This position is listed as contract and hybrid.