Posted to MedZilla on 6/19/2018

Takeda Pharmaceuticals

US-MA, Engineer II, Commercial Technical Operations R0002423-MZ


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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Engineer II, Technical Operations in our Boston, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Engineer II, Technical Operations working on the Pharmaceutical Manufacturing team, you will be empowered and a typical day will include:

The Engineer II, Technical Operations will be responsible for supporting the senior staff within Technical Operations with technical issues relating to the global external manufacturing of commercial Drug Substance. The focus for this position is to provide support within Technical Operations, Drug Substance group.

The individual will be supporting technical activities relating to commercial manufacturing of drug substance and intermediates, drug substance manufacturing process design, optimization, scale-up, technology transfer and validation.

  • Provide day-to-day support to other senior staff members in Technical Operations in managing technical activities for commercial drug substance manufacturing i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.
  • Provide technical support in meetings with third-party drug substance manufacturers or internal manufacturing meetings.
  • Review and/or author validation protocols and reports and provide manufacturing support of validation activities.
  • Compile and analyze production data, such as IPC, release, and manufacturing process information.
  • Prepare presentation of the above data summary to improve manufacturing efficiency and assist in the presentation of such data to other internal and external groups.
  • Author technical reports in support of manufacturing and/or regulatory activities.
  • Provide support in authoring technical sections of dossier and answering questions from Regulatory Authorities in support of submission activities.
  • Comment and assist in the authoring and review of SOP s and manufacturing process instructions/batch records.
  • Provide support in the preparation of change controls, investigations, deviations and CAPAs.


The candidate should have a BS in chemistry, chemical engineering or related discipline and 3+ yrs of experience working in commercial pharmaceutical discipline. The candidate should have a good working knowledge of current good manufacturing practices, and/or drug substance manufacturing (biologics). The candidate also needs to have an excellent knowledge of CMC regulations, cGMPs and aseptic techniques. The candidate should be an expert in Excel as well as other Microsoft Office suite software and data analysis software such as JMP. General understanding of statistical analyses. Experience writing/reviewing manufacturing deviations, investigations and change controls. The candidate should have demonstrated written and oral communication skills and ability to work in a cross functional team environment.


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

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