Sr. IT Specialist, Validation and QualityReq # JR - 031861 Location Deerfield, Illinois Job Category Information Technology Date posted 01/15/2021
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
- Analyze, design, implement and own global R&D IT solutions with focus on scientific and engineering R&D in regulatory environment
- Provide analytical, validation, qualification, change management and administration support for R&D IT tools and applications
- Collaborate with end-users and management to define and document business needs
- Identify cross-functional impact of process changes and enhancements, facilitate solutions to meet organization goals and objectives
- Collaborate with other departments and teams to identify, diagnose, and solve system issues
Essential duties and responsibilities
- Gather and analyze business requirements, develop specifications for medium and large sized systems based on user need and intended use
- Coordinate project planning and execution activities, maintain schedule/budget, track issues/risks
- Plan and execute computer validation activities related to system implementations and change controls
- Develop test plans and scripts, execute test cases, facilitate user acceptance testing, provide end user support
- Assist with troubleshooting, escalation and tracking of application issues
- Manage vendors and third part providers
- Perform tasks with minimum direction, independently manage complex problems, guide others
- Bachelor’s degree in relevant Life Science / Computer Science field
- 5+ years of experience in Life Science / Pharma industry working with scientific systems in validated environment
- 5+ years of experience as business analyst in Life Science or Pharma environment focused on scientific systems in regulatory/validated environment
- Practical experience with GxP, CFR 21 Part 11, computer systems validation and SDLC
- R&D laboratory environment experience; working knowledge of Empower, OpenLab, LIMS or Electronic Lab Notebook systems is preferred
- Excellent verbal and written communication, strong analytical and problem-solving skills, critical thinking ability
- Sense of urgency with strong follow-up skills, ability to multi-task and balance multiple priorities, attention to detail and strong organization skills are essential
- Familiarity working across multiple business domains in support of projects
- Ability to interact with business users, project managers, senior management, outsourced service providers, and vendors
- Self-starter, independent thinker, able to work with minimum direction, high level of initiative and energy
- Proficiency with Microsoft Office products (MS Word, Excel, and Power Point)
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.