Computer Systems Validation Specialist Job Listing at Kelly Services in Wilmington, DE (Job ID 9537729)

Description

Kelly Services is actively recruiting for a Computer Systems Validation Specialist for a Long Term Contract opportunity in Newark, DE.


Qualifications:
The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems. This role will primarily support the Newark manufacturing facility but may require some travel to other North American sites as needed.

Required Skills:

• Bachelor's degree required, preferred in computer science, engineering, or other sciences.
• Minimum of 2-3 years of experience working with automation and/or computerized system validations.
• Must have direct experience in validation of computer/automation/software validation (prepare IQ, OQ, PQ protocol, resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 / 210 / 211.
• Strong written and oral communication skills.
• Strong organizational and time management skills.
• Experience working in a GXP environment.
Responsibilities:
• Support Data Integrity Manager with validation of automated equipment and control systems.
• Responsible for execution of test scripts, creating, and modifying draft protocols
• Responsible for reviewing previously executed CSV activities, identify gaps, including GMP documentation revisions
• Support with creating and modifying validation documentation
• Write reports which summarize the results of the protocol executions.

If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.
 

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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