Job details

Senior Systems Validation Analyst

Premier Research is looking for a Senior Systems Validation Analyst to join our IT 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 the medical innovation that patients are desperate for.

Together, we are Built for BiotechTM. Join us and build your future here.

What You'll Be Doing:

Lead and/or work with users, developers, administrators to develop/assist in the development of: User requirements/design/functional specifications, system test plans/test scripts; lead and/or consult in the execution and documentation of test scripts
Lead validation initiatives and provide mentorship to System Validation Analysts
Identify, plan, and/or schedule project deliverables, milestones, and tasks required to validate/User Acceptance Test (UAT) software releases
Provide guidance on the creation and review of SDLC documentation
Consult and/or work with Corporate Quality in the participation of Vendor Quality Audits and/or Vendor Questionnaires to ensure vendor validation activities are compliant with regulatory requirements (i.e. GxP and European Union regulations)
Oversee, manage and/or consult in ongoing operational/risk assessment activities such as deviations, IT corrective and preventative actions (CAPAs), change management, admin/maintenance reviews/monitoring, systems periodic reviews, etc.

What we are searching for:

Bachelor’s degree and 8 -12 years of relevant software testing or validation experience managing systems validation projects through all aspects of the project life cycle in a CRO and/or pharmaceutical environment, or in systems validation (e.g. Business Analyst, Technical Writer) in the clinical industry
Exceptional experience in at least two generally accepted standards for software/system development, service delivery, and validation methodologies (e.g., GAMP, ISO9000, IEEE, ITIL)
Exceptional experience in supporting testing activities to include test script development including: unit, functional, performance, capacity, stress, and installation
Exceptional experience in 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.
Experience supporting and maintaining systems including: data integration, identity management, infrastructure
Advanced working knowledge of current GxP and European Union regulations as they pertain to computerized systems (e.g., 21 CFR Part 11, EU Annex 11)

Why choose Premier?

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.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

#LI-CI1

Premier Research Glassdoor Company Review

3.8

Premier Research DE&I Review

3.9

CEO of Premier Research

John Ratliff

Approve of CEO

By Premier Research

Premier Research exists to help the world’s most innovative companies transform life-changing ideas and breakthrough science into new medical treatments to answer the unmet needs of patients everywhere. We succeed because we are Built for Biotech...

14 jobs

MATCH

Calculating your matching score...

FUNDING

Private

DEPARTMENTS

Quality Assurance

SENIORITY LEVEL REQUIREMENT

Senior

INDUSTRY

Biotech & Pharmaceuticals

TEAM SIZE