New

Software Validation Lead/Business Analyst

TEKsystems
$50.00 - $65.00 / hr
life insurance, sick time, 401(k), retirement plan
United States, Minnesota, Maple Grove
Aug 23, 2025
Description As a Validation Lead/Business Analyst, you will support the IT Compliance team. You will support several ongoing and new projects across the ecosystem by interacting with various stakeholders to gather requirements and help get them into the Application Lifecycle Management tool. You will help create and maintain validation documentation for new and existing systems. You will ensure that change control and validation activities are executed in a timely manner while following all Policies and Standards. Lead and support Design Qualification processes including: Installation/Operational Qualification (IOQ), Performance Qualification (PQ), System Impact Assessments (SIA), Project Validation Plan (PVP), and User Requirement Specifications (URS) for new installations or major changes. Develop, execute and review FDA validation protocols and related documentation in accordance with procedures and policies Support resolution of validation events and escalate concerns in a timely manner Comply to all FDA policies and standards Use M-Files and WindchillM to house all validation and control documentation * Reviewing and processing change requests for new documents and revisions to existing documents and controlling access of documentation as required by procedures and regulations. * Ensuring that any new documents or changes to existing documents are appropriate, justified, and approved by the required functional areas according to established procedures. * Interact with stakeholders to update requirements * Work directly with management to develop and deliver site guidance on document management processes and roles for the new system. * Updates and maintains document control procedures and participates in the development/improvement and roll-out of document control tools. * As assigned, participate in committees and projects, implement changes, and delivers per the project plan related to the document management system upgrade. * Can plan and coordinate own work according to higher-level project schedules. * Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan. * Ensure documentation accuracy, clarity, consistency, completeness, and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports. * Report unexpected events, issues or software bugs which occur during verification/validation to project team and management. * Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott * Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems. * May Develop and maintain Validation Master Plan(s). Top Skills Details Validation, Software testing, Software validation, Business Analysis Experience Level Expert Level Candidate must be eligible to work as a W-2 employee. Pay and Benefits The pay range for this position is $50.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Maple Grove,MN. Application Deadline This position is anticipated to close on Aug 27, 2025. h4>About TEKsystems: We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. About TEKsystems and TEKsystems Global Services We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.