Posted to MedZilla on 8/17/2019

Takeda Pharmaceuticals

US-GA, Change Control Specialist SR0034957-MZ


Job Function and Description

  • Ownership of all aspects of the manufacturing change control process
  • Lead a team of Department Specialists in support of manufacturing operations
  • Lead deviation investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by:
    • Lead problem solving and root-cause analysis sessionsInteract with Quality, Engineering and Tech Service units
    • Manage complex investigations using DMAIC tools
    • Ensure effective implementation of corrective and preventive actions
  • Management of highly technical/visible Investigations
  • Management of highly technical/visible cross functional projects
  • Owner / point of contact for global initiatives / projects
  • Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs,change controls, etc.)
  • Train staff in general manufacturing activities
  • Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks
  • Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls
  • Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability
  • Stay current with biopharmaceutical industry best practices and technologies
  • Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects.

Education and Experience Requirements

  • Bachelor of Science degree required (prefer Chemical Engineer, Biological/Biotech Engineer or Biotechnology)
  • Minimum eight years relevant professional (GMP industry) experience required
  • Demonstrated ability to perform in a high performing workforce

Key Skills, Abilities, and Competencies

  • Strong knowledge of change control processes and project management required.
  • Strong problem-solving and analytical skills are required.
  • Possess knowledge of core manufacturing principles and support systems.
  • Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
  • Self-driven individual that requires minimal supervision.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
  • Prefer experience in Track-wise system.
  • Prefer experience in Automation Control Systems, EBM (Electronic batch Record), PI Historian.
  • Prefer knowledge of Lean Six-Sigma methodology.

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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EEO is the Law Supplement -

Pay Transparency Policy -

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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