Posted to MedZilla on 8/22/2019

Takeda Pharmaceuticals

US-IL, Validation Associate II SR0036101-MZ


Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people s lives including your own.

BioLife, a subsidiary of Takeda, is an industry leader in operating high quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone.

BioLife s employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off, on the job training, advancement potential AND an environment full of fast-paced fun all while working to save lives.


  • Support the business through qualification and/or validation of computer systems registered as medical devices.
  • Validation activities include but are not limited to: developing test scripts, executing test scripts, performing some software verification, and updating Design History File documents related to changes
  • The position will work in a cross-functional setting throughout the design process, working with but not limited to: IT, Medical Affairs, Quality, Operations, and Regulatory Affairs.
  • This position will support regulatory inspections (FDA, EMA, PPTA, etc.) relating to the validation of computer systems.


  • Work under moderate oversight by senior team member or manager
  • Ability to apply knowledge of, or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
  • Analyze business processes and write system documentation including system requirements, risk assessments, and functional/detail design specifications. Ensure compliance of system documentation with procedures and regulatory requirements.
  • Have an understanding of 21 CFR Part 11 and how it applies to new and existing systems.
  • Understand and follow design control process.
  • Communicate to the business function and IT concerning quality issues.
  • Ensures conformance to established performance requirements and procedures.
  • Handles routine tasks timely and accurately.


Technical/Functional (Line) Expertise

  • Knowledgeble of design control process.
  • Knowledgeable of Data Integrity through the ALCOA standards
  • Creating Funcitonal test scripts/test cases to demonstrate:
    • Boundry testing
    • Corrupt/incorrect/erroneous data entry
    • Field limits/error checking
    • Error handling
  • Create Full Path test scripts/test cases to demonstrate:
    • Processing over a typical range of data
    • Error messages/error handling
    • Regression testing
    • Interface testing between systems


  • All changes made to computer systems will follow design control and be managed as projects requiring communication through various groups.

Decision-making and Autonomy

  • Identify and communicate potential issues throughout testing to the design team.


  • Should be comfortable working independently or in a groups.


  • Computer systems being qualified/validated are a mix of FDA registered medical devices (Blood Establishment Computer Systems) and computer systems considered as non-medical devices


  • Proficient with MS Office, especially Word and Excel.
  • Experience with SQL is preferred.
  • Familiarity with Design Control is preferred.
  • Detail oriented with effective organizational, technical, and problem solving skills.
  • Bachelor s degree in a related field or 3 plus years equivalent experience is required.


  • Some traveling (10%).

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.