Posted to MedZilla on 11/22/2019


Takeda Pharmaceuticals

US-IL, Validation Associate I SR0040003-MZ


 
 

Position is responsible for the management and the execution of project and system qualifications, validations requalification s and revalidations of manufacturing facilities, equipment, utilities and processes. Ensures compliance with regulations and proper documentation. Position may focus on equipment, process or control systems validation.

  • Development and completion of documentation on protocols, Validation Master Plans and Validation Summary Packages.
    • Organizes and performs the logging and archiving of validation documents.
    • Interpretation and application of regulatory requirements concerning validation activities

  • Schedule, plan and manage documents and follow-up on validation projects including:
    • New facility planning
    • Construction and use
    • New equipment selection
    • Acquisition, installation and use, facility/system/process improvements, modifications and additions
    • New product or new product changes and computer-based systems and software.

  • Validation Processes
    • Assist in the creation of validation protocols and requalification programs.
    • Coordinate/perform the test activities necessary to execute the validations.
    • Review/summarize the results and conclusion of the validations.
    • Coordinate any software control activities used in the manufacture, testing approval or documentation of the product.

  • Other Duties/Projects as Assigned
    • Perform technical failure analysis on processes/product not meeting specifications
    • Develop statistical process control programs to monitor processes
    • Report on trends to reduce product/process variability
    • Apply statistical analysis and design of experimental approaches to process development activities.

  • Education & Experience Requirements

    Essential: High School Diploma or GED.

    Desired: Bachelor s degree in a technical area or 6 years related experience.

    Key Skills and Competencies

  • Living our leadership behaviors is a basic expectation for all employees. It is expected all employees to embody the following:
  • Leadership Behaviors

  • Be Positive
  • Be Accountable
  • Be Results Oriented
  • Be An Excellent Manager of Self and Others
  • Must have excellent organizational, oral and written communication skills
  • Must have good word-processing skills and familiar with office software, i.e. MS Word, Excel, etc

  • Other Job Components

    Complexity and Problem Solving

  • Incumbent works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • May determine methods and procedures on new assignments and may provide guidance to lower level personnel.

  • Other Requirements

  • 25% Travel

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

 
 


* 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.