Laboratory Validation Engineer

　　Kelly® Technology is seeking a Lab Validation Engineer for a 12 month + contract position at a Fortune 500 client in Raynham, MA or Warsaw, IN. Manager needs candidates to work in hybrid role.

　　If you’re passionate about driving tomorrow’s technological innovations and are ready to take the next step in your career, trust The Experts at Hiring Experts.

　　Salary/Pay Rate/Compensation:

　　$36-$40/hr plus full benefits through Kelly Services

　　Overview

　　This client is an industry-leading medical device company.

　　The Laboratory Validation Engineer & Test Method Lifecycle Management coordinator is part of the Laboratory Operations department responsible for creating and executing validation deliverables for laboratory instruments and software applications.

　　Laboratory instruments include mechanical test frames, materials analyzers, electronics test instruments, handheld measuring devices, and other types of instruments used within the laboratories.

　　Software validation will include desktop applications designed to operate test instruments, stand-alone desktop applications used for the analysis of test data, configured scripts designed by test engineers (using applications such as Matlab, LabView, Python, R, etc), and spreadsheet templates.

　　The validation engineer will be responsible for defining and executing test cases for validation per established procedures.

　　This role is also responsible for coordination & execution of the Test Method Lifecycle Management program.

　　The Test Method Lifecycle Management program is designed to harmonize how laboratory sites initiate, develop, validate, document, and train on Test Methods within their laboratory.

　　Responsibilities:

　　Responsible, with oversight, for instrument qualification and validation activities of laboratory instruments.

　　Responsible, with oversight, for validation of laboratory software applications.

　　Responsible, with oversight, for ensuring adherence to change control processes for applications and instruments within the laboratory.

　　Assist laboratory SME with authoring instrument or software user guides and processing guides through the change control process.

　　Responsible, with oversight, to define the ideal process for Test Method Lifecycle Management process for use within the laboratories.

　　Coach laboratory staff members in the execution of Test Method Lifecycle Management.

　　Qualifications:

　　Education:

　　Bachelor’s Degree required, preferably in an Engineering, Science, IT, or related field.

　　Required:

　　Minimum of 2 years’ experience in a regulated industry.

　　Experience with software validation processes and principles, specifically of configured elements within a regulated software environment.

　　The ability to review and critically assess processes.

　　Strong analytical skills, especially in the areas of process improvement, problem solving, and logical thinking is required.

　　Ability to work unsupervised on assigned tasks.

　　Strong attention to detail, demonstrated enthusiasm and willingness to learn.

　　Must be highly organized, able to work on concurrent projects and meet tight deadlines.

　　Ability to coordinate & communicate with external partners/vendors in a timely manner.

　　Preferred:

　　Experience with Agile project management techniques.

　　Experience with Jira.

　　Experience with laboratory instruments (Instron, MTS, AMTI, etc) is a plus.

　　Experience with laboratory applications is a plus (Matlab, LabView, Python, R)

　　Experience with software validation is a plus.

　　Experience with PLM applications is a plus (ie Windchill).

　　Experience with technical writing, procedure development, and process development including process mapping and improvement techniques.

　　Strong analytical skills, especially in the areas of process improvement, problem solving, and logical thinking is required.

　　What happens next:

　　Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in the Kelly Technology network. That means our team of expert technology recruiters will have access to your profile, making your opportunities limitless.

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　　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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Engineering/Technology – Project Services?

　　Looking to work with leading project management organizations at top companies around the world? That’s where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world’s most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects—all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That’s just good planning.

　　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 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.