Systems Validation Analyst II
About the role
Premier Research is looking for a Systems Validation Analyst II to join our IT & Corporate Administration team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here.
Responsibilities
- Lead and/or support users, developers, and administrators in developing user requirements, design/functional specifications, and system test plans/scripts, including guidance on execution and documentation of test scripts
- Identify, plan, and schedule project deliverables, milestones, and tasks required to validate/UAT software releases; research, develop, and write validation/UAT content
- Provide guidance on SDLC documentation creation/review, and prepare/maintain documentation relating to users, systems, programming, operations, products, services, testing, and validation, including graphical images, flow charts, and diagrams
- Lead and/or participate in developing SOPs to ensure regulatory compliance, and ensure adherence to SOPs, regulatory validation, and quality assurance plans by software developers and customers
- Act as independent quality reviewer for peer software validations while remaining open to critical review of own work, ensuring project validation documentation meets all project and SOP requirements to support audits
- Advise IT resources/business SMEs and maintain systems validation documentation; lead/consult on ongoing operational/risk assessment activities (change management, admin/maintenance reviews, periodic reviews)
- Up to 20% overnight travel required
Requirements
- Bachelor's degree, or international equivalent, in Computer Science/Information Technology, Business Management Information Systems, or related discipline, or equivalent relevant experience
- BS degree and 2-4 years direct experience managing low to moderate scope systems validation projects through all aspects of project life cycle, or 4-6 years of relevant experience in systems validation with a CRO, Biotech, Pharma
- Experience in at least one generally accepted standard for software/system development, service delivery, and validation methodologies (i.e. PDA, GAMP, ISO9000, IEEE, ITIL, CobIT)
- Proven track record of test script development technologies including unit, functional, performance, capacity, stress, and installation
- Solid experience gathering and writing functional and system requirement documentation, pseudo logic, risk assessments, traceability matrices, bug tracking, validation plans, final reports, system support documentation
- Familiarity with/experience in the following systems/supporting systems a plus: Data Integration Platforms, ERP, Clinical Systems, Networks and Infrastructures
- Current working knowledge of current GxP and European Union regulations as they pertain to computerized systems
Pay
The annualized minimum base pay for this role is $100,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Benefits
We offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.