- 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, analyze and document business objectives, specifications, and requirements for medium and large sized systems based on business need and intended use
- Evaluate, plan, design, test and execute computer validation activities for system implementations and change controls
- Develop test plans, execute unit system test cases and scripts, facilitate user acceptance testing, provide end user support
- Assist with troubleshooting, escalation and reporting of application issues, manage issue tracking, develop contingency plans, perform risk analysis
- Manage vendors and third part providers
- Create and maintain comprehensive project documentation, including project schedule and budgets
- Perform tasks with minimum direction, independently manage complex problems and guide others
- Bachelor's degree in relevant Life Science / Computer Science field
- Minimum 5 years of experience in Life Science / Pharma industry working with scientific systems in validated environment.
- Minimum of 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 and computer systems validation.
- R&D laboratory environment experience, working knowledge of Empower, OpenLab, LIMS or Electronic Lab Notebook systems is preferred
- Practical experience with project
- 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
- Ability to work with diverse teams in global setting and demonstrate leadership competencies and vital behaviors.
- Strong interpersonal and team-working skills, leadership competencies and vital behaviors
- Ability to understand and work 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).