Premier Research is looking for System Validation Analyst II to join our Technology Ops & Apps 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 Built for You. 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.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
Position Summary:
The Systems Validation Analyst performs business analysis, systems validation, and testing processes required to support the software development and implementation processes for both regulated and non-regulated systems. Responsibilities include working closely with business subject matter experts to define and document requirements and business processes that drive the features in the software used to support various segments of the clinical trials process.
What You’ll Be Doing:
- Work with users, developers, administrators to develop/assist in the development of: User requirements/design/functional specifications, system test plans/test scripts
- Participate in ongoing operational/risk assessment activities such as change management, admin/maintenance reviews/monitoring, periodic reviews, etc.
- Identify, plan, and/or schedule project deliverables, milestones, and tasks required to validate/User Acceptance Test (UAT) software releases
- Maintain systems validation documentation repository including systems inventory list and inventory of changes
- Ensure adherence to Standard Operating Procedures (SOPs), regulatory validation, and quality assurance plans by software developers and their customers
What We Are Searching For:
- BS degree and 4-6 years direct experience managing systems validation projects through all aspects of the project life cycle in a CRO and/or pharmaceutical environment, or 6-8 years of relevant experience in systems validation (e.g. Business Analyst, Validation Analyst)
- Experience in at least one generally accepted standard for software/system development, service delivery, and validation methodology (e.g., GAMP, ISO9000, ITIL)
- Experience gathering and writing functional and system requirement documentation, risk assessments, traceability matrices, bug tracking, validation plans, final reports, system support documentation, change management documentation, etc.
- Solid working knowledge of current GxP and European Union regulations as they pertain to computerized systems (e.g., 21 CFR Part 11, EU Annex 11)
- Excellent verbal and written communication skills to work across the organization and interact/influence/negotiate effectively at all levels
Why Choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
