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:
How you will contribute:
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
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.
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.
Be able to improve one’s own work and provide ideas to improve team performance.
Work in a culturally diverse, complex global-matrixed organization.
What you bring to Takeda:
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)
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
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.
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.