Posted to MedZilla on 5/21/2019

Takeda Pharmaceuticals

US-IL, Manufacturing Associate SR0034642-MZ


The Manufacturing Lead is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, he/she may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

  • Initiate and execute level 1 and level 2 deviations, including root cause investigations, corrective actions, and effectiveness checks.
  • Investigate any process problems timely and provide documentation.
  • Participate on Continuous Improvement Teams and may serve in a leadership role.
  • Ensure timely and accurate generation of process documentation. Review documentation.
  • Assist supervisor in organizing, scheduling and directing other team members.
  • Main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, and validation.
  • Involved in hands-on execution of manufacturing operations.
  • Resolve issues related to equipment, process and compliance. Main troubleshooting/response person.
  • Train and mentor other team members and monitor training for newer team members.
  • Assist with process/equipment validation and data analysis
  • Assign other project work and/or involvement in teams to team members.
  • Represent the dept. in cross functional teams as necessary.
  • May perform other duties as assigned.

  • Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties.
  • Good computer skills, knowledge of Microsoft Word and Excel.
  • Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
  • Must be able to apply quantitative analysis to analyze process performance.
  • Knowledge of basic chemical and biological safety procedures.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural and technical writing skills.
  • Knowledge of chemical and biological safety procedures a plus.
  • Must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment.
  • This position requires shift, weekend and holiday work. Overtime may be required at times.
  • The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
  • May require immunization before performing work within the manufacturing area.

Associate s or Bachelor s degree preferred with a minimum of 4+ years of manufacturing experience

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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