Posted to MedZilla on 2/22/2020


Takeda Pharmaceuticals

US-IL, Validation Associate I SR0046369-MZ


 
 

OBJECTIVES/PURPOSE

  • Manage the BioLife equipment life-cycle qualification, validation, calibration, maintenance, repair, decommissioning
  • Provide support for project teams
  • Drive continuous improvement

ACCOUNTABILITIES

  • Develop and execute protocols to support changes
  • Manage equipment repairs and calibration tasks
  • Manage freezer validations and supporting processes
  • Problem solving for equipment issues as necessary
  • Report on and manage BioLife equipment metrics and trends

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Experience in a regulated industry

Leadership

  • Ability to drive decisions through Influence
  • Self-motivated
  • Strong communication skills (written and oral)
  • Team oriented
  • Ability to manage, prioritize and deliver on core responsibilities

Decision-making and Autonomy

  • Comfortable making decisions with limited information
  • Ability to identify and resolve problems as they arise with moderate oversight
  • Ability to understand the risks and benefits surrounding decisions

Interaction

  • Customer focus willing to help, respectful, prompt and accountable
  • Partners with Quality and Center Operations

Innovation

  • Open to new ideas
  • Embraces change
  • Confidence to challenge the status quo

Complexity

  • Ability to thrive in a dynamic setting
  • Ability to break down complex situations into manageable pieces
  • Ability to see the big picture and considers upstream and downstream impact of decisions

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Essential

  • At least 3 years of experience in a regulated industry
  • High-school diploma or GED
  • Experience with Microsoft Word, Excel and SharePoint

Desired

  • Bachelor s degree in science or Engineering
  • Experience with equipment repair
  • Validation experience
  • Understanding of plasma collection business and associated regulations

ADDITIONAL INFORMATION

  • This position requires ability to travel up to 25%

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.