Validation Scientist Job Listing at Kelly Services in Wilson, NC (Job ID US3564789_BH9840722)

Description

GMP Systems Administrator –Validation Scientist

Location: Wilson NC
Schedule: Monday-Friday first shift 
Hourly Pay Rate: $40-$60 depending on experience
Temporary to hire 

A leading commercial laboratory testing organization is seeking a GMP Systems Administrator - Validation Scientist to oversee GMP software validations and lab IT system compliance across its regulated environments. This pivotal role ensures that all computerized systems—including laboratory instrumentation software—are validated, compliant, and maintained in a controlled state per regulatory standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).

This position bridges IT system administration with quality and regulatory oversight, partnering with laboratory staff, QA teams, and vendors to implement, validate, and maintain systems for use in a GMP-compliant setting. Familiarity with chromatography data systems (e.g., Chromeleon, Empower, OpenLab) is highly desirable.

Key Responsibilities:

• Lead and execute software validation activities (IQ, OQ, PQ) for lab systems including CDS, LIMS, and standalone instrument software.

• Maintain validation documentation in alignment with internal SOPs and regulatory requirements.

• Act as the subject matter expert for Computerized System Validation (CSV); support audits, inspections, and CAPAs.

• Ensure instrument PCs and lab systems are secure, validated, backed up, and compliant.

• Manage software deployment, configuration, and qualification of lab instruments (e.g., HPLC, GC, UV).

• Coordinate with QA and Lab Management to assess validation needs for changes to software or hardware.

• Provide Tier 2/3 support for laboratory IT systems and manage escalation processes.

• Develop and implement backup and restoration procedures for GMP systems.

• Conduct periodic reviews of GMP systems (user access, audit trails, performance).

• Maintain inventory and validation status of all systems.

• Support lifecycle activities such as URS development, risk assessments, vendor qualification, change control, and decommissioning.

• Collaborate with vendors on upgrades and service contracts to ensure continuous validation.

• Deliver training and create SOPs for end-users of validated systems.

Minimum Requirements:

• Bachelor's degree in Computer Science, Information Systems, Life Sciences, or a related technical field.

• 5+ years of experience with GMP computer systems and software validation.

• Strong working knowledge of FDA 21 CFR Part 11, GAMP 5, and CSV best practices.

• Technical expertise with system administration and lab instrumentation software.

• Strong documentation skills and experience with validation protocols and reports.

• Proficiency with system backup/recovery in regulated environments.

• Familiarity with Windows Server, Active Directory, and Group Policy.

Preferred Qualifications:

• Experience supporting analytical lab instruments (HPLC, GC, etc.) and IT infrastructure.

• Knowledge of LIMS and other lab data management systems.

• Experience with virtualization platforms (VMware/Hyper-V), cybersecurity principles, and remote support tools.

• Background working in FDA-regulated (GxP) laboratory environments.

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® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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.

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