Senior Solution Engineer, Quality Management Systems応募 後で応募 求人ID R0012846 掲載日 10/01/2019 Location:Lexington, Massachusetts; Exton, Pennsylvania
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Solutions Engineer, Quality Management Systems in our Lexington, MA or Exton, PA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Senior Solutions Engineer working on the Quality Management Systems
team, you will be empowered to lead analysis, define and establish design of all technical aspects and/or provide technical expertise for IT solutions. In this role, you will contribute to Takeda’s mission by delivers system solutions and support for Quality Management System processes across the TrackWise platform. A typical day will include:
- Leads analysis, defines and establishes design of all technical aspects or provides technical expertise for IT solutions on intermediate and large complexity IT systems and/or projects within area of expertise.
- Maintains and uses knowledge of solutions and IT landscape to explore and identify possible solutions related to defined technical problems, and finds opportunities to improve business solutions support.
- Maintains and partly creates elements of complex solutions.
- Delivers system solutions and supports for Quality Management System processes across the TrackWise platform.
- Serves as the Senior Technical SME and Administrator for QMS applications and other technologies as assigned.
- Supports design, implementation, governance and run activities in collaboration with cross-functional business and IT areas.
- Manages the development lifecycle of workflows across the TrackWise platform.
- Develops and configures business workflows independently. Evaluates user requirements.
- Develops and implements reports and dashboards using Crystal Report, QlikSense or other equivalent tools.
- Solves unique and complex technical problems that occur during daily operations. Acts as a point of escalation for moderate, non-routine technical problems.
- Provides support and troubleshooting for system issues as required. Manages resolution accordingly.
- Develops, executes and manages technical specifications, test cases, and documentation as per Software Development Lifecycle (SDLC), Agile Scrum and Information Technology Infrastructure Library (ITIL) standards, procedures and policies.
- Executes and supports testing, validation and maintenance of system activities.
- Ensures proper configuration management and change controls are implemented.
- Manages, coordinates and coaches the performance of deliverables with third party vendors, professional services, and/or consultants as per plan.
- Maintains technical relationships with vendors in support of projects and ongoing operations.
- Works with IT business analyst and key users to understand business needs, problems to translate to solutions and the IT landscape.
- Develops technical roadmaps and operational plans for complex business solutions, in order to develop/improve functionality within solutions or the technical landscape.
- Maintains and influences technical roadmaps, ensures that operations are aligned with roadmaps and communicates status to projects.
- Evaluates emerging technologies relevant to Quality and leads proof-of-concepts.
- Provides continuous improvement for technology best practices and guidelines.
- Coaches or leads lower-level Engineers and other technical groups.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor Degree or equivalent in Business, Computer Science, Information Systems, or equivalent education.
- 5 years or more of relevant experience.
- Expertise and experience in TrackWise administration, configuration (TeamAccess, WebAdmin, PR Import, Selection Import, Admin Queries, Workflows), Java web services and Crystal Reports development.
- Technical experience in relational database management software including Oracle and MS SQL, specifically SQL querying and navigating complex data structures.
- Knowledge of computer systems validation practices.
- Extensive experience implementing solutions and using different Quality Systems in the pharmaceutical or Life Science Industry
- Strong analytical and problem-solving skills.
- Ability to write and speak in the English language.
- Excellent oral and written communications skills, business acumen with problem solving and analytical skills.
- Up-to-date expertise in the solution area assigned and continuously enhances own skills.
- Is considered a subject matter expert in the technical area of expertise.
- Master Degree.
- TrackWise implementation experience in Pharma/Life Sciences/Medical Device companies.
- Experience and knowledge of Agile methodology for continuous implementation.
- Expertise and experience in QlikVi
- ew and/or QlikSense reporting development.
- Experience with other tracking software systems or quality management system applications is preferred.
- Quality business process knowledge in Change Controls, Complaints, Deviations, CAPAs, Supplier Management, and Audits.
- Understanding of IT service management processes and associated tools (e.g. ServiceNow).
- Experience of managing third party vendors and off-shore technical teams.
- ITIL Intermediate level.
- Agile (Scrum)
- Access to transportation to attend meetings.
- Ability to fly to meetings regionally and globally.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.