New

Validation Analyst/Engineer: 100% REMOTE

TEKsystems
$30.00 - $55.00 / hr
life insurance, sick time, 401(k), retirement plan
United States, Indiana, Indianapolis
Feb 25, 2025
W2 ONLY EST TIME ZONE, MUST LIVE IN EST or CST 100% REMOTE Having some SOX experience would be a plus and having some SAP experience would also help. Validation Engineer/Tester Scope of Services: Create, maintain, and/or provide guidance to IT and the business for required computer system validation efforts for computer systems and/or infrastructure platforms. This role description is a general list of expectations for the role, however each IT team may dictate other duties as assigned. Overarching expectations: oValidation/Qualification deliverable creation and maintenance adhering to the compliance policies and procedures. This includes but not limited to FDA, MHRA, ISPE GAMP regulations as needed. oTechnical writing expertise including adhering to overarching regulations such as FDA, MHRA, ISPE GAMP, etc. oIf working in a regulated area (ie., GxP, USDA), a thorough working knowledge of 21CFR Part 11, Annex 11, USDA, ect.is essential as needed. oClear communication skills to provide direction, communicate expectations and articulate opinions and solutions. oProject validation/qualification deliverable oversight including the creation, maintenance, review and approval routings. oPartner with IT SMEs, providing consultation on Quality policies and procedures. oPartner with SMEs (business and IT) for delivery of complete and accurate documentation. oEscalate compliance concerns immediately to the CSQA Representative. oMeet all deadlines and escalate concerns of potentially missed deadlines immediately when encountered to the Team Lead or Project Manager. oCommunicate effectively with team members and other applicable groups to ensure consistent and complete documentation. oSelf-manage assigned tasks according to required timelines, take initiative to consult with the team and drive delivery of validation/testing deliverables oUnderstand and document relationships and dependencies between various phases of the project and the software development lifecycle model. oComplete other IT Quality activities as assigned by the IT team. oFollow best practice guidelines for data and documentation while developing CSV documents oBe inquisitive. Ask your IT team questions, understand your system's basic intent and function in order to best help the client in meeting Compliance Standards. oAlign with IT quality organization and CSQAs to ensure alignment with compliance Validation/Qualification Documentation: oSchedule meetings and facilitate System Validation Risk Assessment discussions and document results. oDrive the development of the Validation (or Qualification) Strategy document with input from appropriate SMEs. Various types of system and functionality are included in this development effort. The appropriate understanding of the purpose of the system is required along with the ability to consult on risk based, rightsizing activities. oCreate, with the appropriate IT SMEs, applicable supporting system documentation. oPlan and create documentation required for compliance with the applicable departmental policies and guidelines. oTrack non-compliant and outstanding documents and actions in accordance with processes and recommendations of the Quality Representative. oFunction as the point of contact for Validation/Qualification documentation. oAcquire and apply business knowledge and overarching standards that apply to the project scope. oCollaborate with Business and IT SMEs to identify documentation points which ensure a functional, viable relationship between requirements and technical specifications. oReport status of Validation and Qualification deliverables to project teams and/or Quality team as applicable in a timely manner. oAcquire and apply knowledge of IT tools (e.g. ServiceNow and Veeva QDocs) as needed, to complete objectives. oCollaborate with appropriate CSQA for any compliance related questions or decisions, as appropriate. Pay and Benefits The pay range for this position is $30.00 - $55.00/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 remote position. Application Deadline This position is anticipated to close on Mar 7, 2025. 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.