Validation Engineer Job Listing at Kelly Services in Rochester, NY (Job ID US3533703_BH9716066)

Description

Kelly Engineering is hiring for a Validation Engineer role with a renowned Medical Device company in the Rochester, NY area. This Validation Engineer will be an integral part of the development process engineering team supporting all lab verification/validation needs. This position will be involved in all aspects of DPE IT projects and will support other lab equipment projects as needed. This is a long-term, contract role with competitive pay.

Responsibilities:

• Translate user needs into technical requirements and ensure the requirements are properly documented (user requirements specification, functional specification, etc.).
• Lead or assist programmers with appropriate software design documentation (design specifications, release notes, etc.).
• Develop appropriate testing strategies to confirm software meets the user and quality system requirements and is appropriately documented (test scripts, qualification protocols).
• Manage software/equipment/process qualifications and validations with generation of appropriate documentation.
• Coordinate data reporting strategies to meet business needs
• Provide support to Software Quality Assurance representatives during MES validation of change control process.
• Participate with the engineering and operations teams to define plans for integrating, standardizing, scaling and enhancing our products and the services utilized to deploy/install/release those products.
• Expand and develop site specific reports in the MES application including requirements capture, development, testing and deployment.

Requirements:

• Degree in Science/Engineering with Quality Engineering experience and/or certification as a Quality Engineer (or related role).
• 3-9 years' experience in a technical role. 
• Computer competent with SQL and Oracle. 

Other Experience:

• Familiar with CFR Part 11 requirements, experience with change control requirements, experience with software development lifecycle. 
• Communication, organization, report writing a must.    
• Must be able to develop working relationships with various internal core competencies and work as a team member.
• Special Skills: Good understanding of software engineering practices, ISO-9000, GMP, medical device manufacturing experience, technical writing, equipment and software qualification and documentation, excellent communication skills.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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