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Job Description

About the role:

The Sr. Systems Analyst collaborates with the business and global DD&T teams to provide support for MA Biologics Operations Site Functions – partnering with the Quality Control organization. The Sr. Systems Analyst manages their work by maintaining project and operational support programs, providing oversight of vendor-provided solutions, handling ad-hoc technical requests from both internal and external partners. The Sr. Systems Analyst is an important member of the MA Biologics Operations Digital and Lab Systems Quality team and is a focal point for customer engagement for programs as assigned by the Lab Systems IT Applications Manager. You will report to the Manager of Quality Control IT Lab Systems. You will report to the Lab Systems IT Applications Manager.
How you will contribute:

• Work with partners to understand end-user requirements and provide operational oversight for implementing approved global solutions
• Remain current on technology trends in the market and evaluate for potential value to the company
• Establish and coordinate programs that are part of the Quality and Lab of the Future roadmap and existing lab systems IT portfolio
• Participate in Business meetings to understand our requirements
• Work with project teams (DD&T,Capital, Validation, and QA) during planning and design phases to ensure appropriate solutions
• Consult during the selection of external service providers
• Evaluate proposed IT infrastructure changes to determine potential impacts to systems operations and compliance
• Be a subject matter expert for applications
• Provide configuration solutions and advice and develop customizations, within the context of technical standards
• Develop new features requested through requirements gathering from projects, pilots or tests and implement these features specifically or as the situation dictates
• Create SDLC documentation – Function Requirement System(FRS), System Design and Configuration Specification (SDCS), System Admin SOP and Operation and Maintenance SOP (O&M)
• Help with and contribute to application validation efforts, including installation qualification, operational and performance qualification
• Work with DD&T infrastructure Partners to ensure optimum operational performance of delivered solutions
• Provide support during FDA/Regulatory Authority Inspections and Readiness for Lab Systems IT SME Support.

What you bring to Takeda:

• More than 5 years relevant IT/business experience, analysis, and documentation of business and technical requirements (required)
• Experience with software application implementations in GxP environment (required)
• Bachelor’s degree in information technology, computer science, engineering or relevant field (required)
• Experience in the Pharmaceuticals or Life Sciences industry
• Experience consulting or working in a complex, global matrix organization
• Knowledge of Lean operational techniques
• IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments – Empower, Chromeleon, SOLO VPE, GE Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, GE DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX, PerkinElmer Asset Genius, Thermo WebAdmin for TruScan RM Analyzer, and multiple Laboratory desktop applications used in GxP environment
• Familiarity with Automation systems such as SCADAs, PLCs, DCS, BAS, Historians
• Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance
• Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
• Familiarity with following tools – TrackWise – CAPA, Deviation, Change Control, Veeva – Document Workflows, SAP Success Factors – Training Compliance
• Familiarity with Operational Excellence and Continuous Improvement processes
• Knowledge and familiarity of following Technologies
• MS Office 365, MS Visio, MS Project
• Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore
• Architectures – 2 Tier, 3 Tier, On-premise, Cloud

Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

#GMSGQ #ZR1 #LI-MA1 #LI-Onsite

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA – MA – Lexington – BIO OPS

U.S. Base Salary Range:

$108,500.00 – $170,500.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.


USA – MA – Lexington – BIO OPS

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Full time

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