Computer Software Validation Specialist
ManpowerGroup
Our client, a leading organization in the healthcare and laboratory industry, is seeking a Computer Software Validation Specialist to join their team. As a Computer Software Validation Specialist, you will be part of the Quality & Compliance department supporting laboratory and validation teams. The ideal candidate will demonstrate meticulous attention to detail, strong problem-solving skills, and excellent communication abilities, which will align successfully within the organization.
**Job Title:** Computer Software Validation Specialist
**Location:** Wilson, North Carolina
**Pay Range:** $50
**What's the Job?**
+ Lead the technical execution of validation for laboratory instrument software across R&D and Quality labs.
+ Manage the entire CSV lifecycle—from risk assessment and validation planning to protocol generation, test execution, deviation management, and final reporting.
+ Ensure compliance with 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and internal QMS/SOPs.
+ Develop validation plans, URS, FS/DS, and traceability matrices to support validation activities.
+ Collaborate with cross-functional teams including Lab, QA, IT, and vendors to support validation and audit readiness.
**What's Needed?**
+ Minimum of 5+ years of hands-on experience in CSV within GxP environments.
+ Strong knowledge of risk assessments, URS, IQ/OQ/PQ, deviations, and validation reports.
+ Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, and ALCOA+ principles.
+ Experience with lab instrument software and validation of electronic systems.
+ Degree in science or engineering is preferred.
**What's in it for me?**
+ Opportunity to work in a dynamic and innovative environment focused on quality and compliance.
+ Engage in meaningful projects that impact laboratory and healthcare advancements.
+ Collaborate with a diverse and talented team of professionals.
+ Gain valuable experience in regulatory compliance and validation processes.
+ Support your career growth within a reputable organization committed to excellence.
**Upon completion of waiting period, consultants are eligible for:**
+ Medical and Prescription Drug Plans
+ Dental Plan
+ Vision Plan
+ Health Savings Account
+ Health Flexible Spending Account
+ Dependent Care Flexible Spending Account
+ Supplemental Life Insurance
+ Short Term and Long Term Disability Insurance
+ Business Travel Insurance
+ 401(k), Plus Match
+ Weekly Pay
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
**About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.**
_ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _– creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent._
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
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