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DD&T Sr. Applications Specialist

Location
Woburn, Massachusetts
Posted
22 Sep 2022

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Job Description

Position: Data, Digital, and Technology (DD&T) Sr. Applications Specialist

Location: Lexington, MA - this is a hybrid workplace position

About the role:

DD&T Sr. Applications Specialist provides data, digital, and technology solutions at MA Biologics Operations plants and warehouses.  As a member of site DD&T (Previously IT) team, you will collaborate with business functions, QA, and local/remote DD&T teams to implement and maintain GxP & non-GxP systems.  The purpose of this role is to:

  • Deliver data in a form that enables smart decision making and goals for KPI management
  • Support end-to-end system integration, data flow, and data governance
  • Drive automation by use of data, processes, and technology
  • Visualization and facilitation of process KPIs for process control and improvement
  • Scout and pilot digital innovations.

How you will contribute:

  • Improving existing systems and automating processes by implementing data, digital, and technology solutions
  • Documenting processes and system design (Visio) and system development lifecycle (SDLC) documents (Word)
  • Coordinates between multiple DD&T teams including site and global IT infrastructure teams for deploying and troubleshooting applications (Environment Monitoring, Analytical Instruments), Servers (Windows), Databases (SQL), and end-user devices (printers, barcode scanners, computers)
  • Initiates IT change ticket and installs and configures application software per documentation.
  • Follow Takeda's SDLC, CSV or AIQ, and documentation standards to author and execute IQ/OQ scripts for qualification
  • Deploy computer system, mobile devices, printer, etc. and ensure connectivity and normal operations
  • Resolve technical issues and provide operational support (perform periodic maintenance, etc) in adherence to Service Level Agreements (SLA) and following Takeda's ITIL processes
  • Obtain quotes for hardware/software and initiate procurement requests

Technical/Functional (Line) Expertise

Windows Computer Hardware, Windows Desktop and Server Operating System, Active Directory, SQL Database, Networking, Security, Backup and Restore; Printers; Mobile devices

Leadership

Career-driven, self-motivated, and willing to learn new systems and skills.  Must be able to work in a fast-paced environment, under pressure to minimize/avoid impact to site operations.  Will be expected to respond to on-call support off-hours and/or on weekends, if required.  Be able to self-manage and prioritize daily work.

Decision-making and Autonomy

Be able to independently troubleshoot computer hardware and application issues (where to look and what to look for), determine the root cause (e.g. by elimination), and implement resolution by putting two and two together i.e. draw a conclusion based upon the given evidence.

Interaction

Fluent in English, be able to communicate the technical subject matter in plain English to a non-technical audience.  Communicate with technical IT teams - compute/storage, networking, security, backup/restore, database, software vendor, etc.

Innovation

Be able to improve one's own work and provide ideas to improve team performance.

Complexity

Work in a culturally diverse, complex global-matrixed organization.

What you bring to Takeda:

Essential Skills

  • Bachelor's degree is required, preferably in information technology, computer science, or engineering.

  • Minimum 7 years of IT experience with at least 5 years of software application implementation & support at a Pharmaceutical Biologics Manufacturing Facility.

  • The ideal candidate will have experience with a couple of such systems: e.g., Environment Monitoring, Analytical Instruments, LIMS, Document Management, CMMS, preferably in a GxP compliant industry

  • Working knowledge and experience with the following technologies are required:

    • Windows Hardware, Desktop & Server OS, SQL Database and scripts, Active Directory, Basic Networking, Backup\Restore, Citrix/RDS

    • Thick and thin client application architectures

    • Barcode scanners, printers (Zebra label, P-touch)

Desired Skills:

  • Familiarity with the following GxP processes used in the pharmaceutical industry: Computerized Systems Validation (CSV) or Analytical Instrument Qualification (AIQ); 21 CFR Part 11 regulations and Data Integrity compliance

  • Familiarity with the following tools and processes:

    • ServiceNow - ITIL processes such as Incident Management, Change Management, Request Management, Asset, and Configuration Management (CMDB); Track Wise QMS - CAPA, Deviation, Change Control; HP ALM or Kneat - Electronic Testing; Veeva EDMS - Document Workflows and MS Visio and Project

Potential Domestic travel.  Drive to various sites within MA - Lexington, Alewife, Belmont, and North Reading.

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision

  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

  • 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 and company match, of charitable contributions

  • Family Planning Support

  • Professional training and development opportunities

  • Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

#GMSGQ

#ZR1

#LI-MA1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Details

  • Job Reference: 718550670-2
  • Date Posted: 22 September 2022
  • Recruiter: Takeda Pharmaceutical
  • Location: Woburn, Massachusetts
  • Salary: On Application