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Equipment Validation Engineer

Kelly Services is currently seeking a Validation Engineer position for one of our top clients in Raynham, MA or West Chester, PA.

+ Kelly Outsourcing Consulting Group KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Validation Engineer for a long-term engagement at one of our Global clients in Jacksonville, FL. This role is a full-time, fully benefited position.

+ As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from.

+ You’ll also be eligible for paid time off, including holiday, vacation and sick/personal time.

+ All KellyOCG employees receive annual performance reviews.

As an Equipment Validation Engineer placed with KellyOCG you will be responsible for the following:

We are seeking a Senior Equipment Validation Engineer to lead equipment validation activities in a regulated medical device laboratory. This senior role owns validation execution for laboratory testing equipment, ensuring systems meet design, regulatory, and quality requirements. You will drive continuous improvement and work cross-functionally across the global lab network, quality, and external suppliers.

+ Lead equipment validation lifecycle activities per procedure: User Requirements Specification (URS), Design Qualification (DQ) support, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

+ Develop, review and approve validation deliverables: plans, protocols, test scripts, validation summary reports, and SOPs.

+ Plan and execute Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT); coordinate vendors and cross-functional stakeholders.

+ Support supplier qualification and technical negotiations with vendors; ensure vendor deliverables meet validation requirements.

+ Lead instrument decommissioning activities, which may include transfer of capabilities to other laboratory locations.

Experience (Required):

+ 4+ years of experience in a regulated laboratory or manufacturing industry

+ Bachelor’s degree required, preferably in Engineering, Science, IT or related field.

+ Demonstrated ability to lead cross-functional projects, influence stakeholders, and manage multiple priorities.

+ Proven track record authoring and executing IQ/OQ/PQ and leading FAT/SAT activities for complex systems.

+ Excellent technical writing skills and attention to detail.

+ Experience with PLM applications (i.e.. Windchill).

+ Ability to lead a project through to completion.

Preferred:

+ Experience with Jira

+ Experience with Agile project management techniques

**Important information:** This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

Why Kelly** **®** **?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

As a Kelly Services employee, you will have access to numerous perks, including:

+ Vacation and sick pay

+ Paid holidays

+ 401(k) plan

+ Group medical, vision, dental, life, and short-term disability insurance options

+ Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools

+ Kelly Learning Center offers free courses and trainings

+ Weekly pay

About Kelly Services** **®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook (https://www.facebook.com/kellyservices) , LinkedIn (http://www.linkedin.com/company/kellyservices) and Twitter (https://twitter.com/kellyservices) .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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.

Find what’s next with Kelly ® .

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.

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.