Computer Systems Validation Specialist - PLM Implementation

Job Title: Computer Systems Validation Specialist - PLM Implementation
Location: Cary, IL or Remote
Type: 9 month contract
Compensation: $44-48/hour, depending on qualifications
Work Model: Remote – offsite
Hours: 40.0

Overview:
Supports Product Lifecycle Management (PLM) implementation by developing validation documentation, supporting system configuration, executing user acceptance testing, and ensuring compliant system adoption in a regulated environment.

Responsibilities:

• Develop user requirements, functional requirements, and validation documentation supporting PLM implementation.
• Support PLM configuration, workflow reviews, data mapping, and system readiness activities.
• Develop and execute User Acceptance Testing (UAT), manage defects, and validate system functionality.
• Author CSV deliverables, including URS, FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols, and validation summary reports.
• Collaborate with IT, Quality, vendors, and project teams to support system implementation, documentation, and validation activities.

Requirements:

• Bachelor of Science in Computer Science, Engineering, Business, or a related discipline.
• 3+ years of experience in Computerized System Validation (CSV/CSA) with strong document authoring experience.
• Experience with GxP/FDA-regulated systems, requirements gathering, functional analysis, and User Acceptance Testing (UAT).
• Experience supporting QMS, PLM, or document management systems; prior PLM implementation and validation experience preferred.
• Preferred: Experience with PLM software such as Agile or MasterControl and knowledge of cGMP, cGDP, and 21 CFR Part 11 regulations.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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