Posted to MedZilla on 8/18/2019

Takeda Pharmaceuticals

US-MA, Senior Manufacturing Technician SR0038273-MZ



For the initial period, this position will report to Sun - Wed, [Afternoons/Evenings, 12:30 pm to 11:00 pm] 10 hours shift. In the near future, the shift structure will change to the

Pitman schedule, [Nights, 6 pm 6:30 am], 2-2-3, 12.5 hours shift, off every alternate weekend.

Primary Duties:

With limited supervision this individual will perform routine and non routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas.

Operates production equipment according to SOPs for the production of clinical and/or commercial products. Will support engineering and validation activities.


70% This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Responsibilities include:

  • Troubleshoot and resolve process related issues
  • Create work orders as needed
  • Initiate and document minor deviations
  • Execution of critical and routine and non routine production operations
  • Informing management of events impacting schedule
  • Perform Batch Record, Log Book and Form Prep requests
  • Enter data in the Laboratory Information Management System (LIMS)
  • Record data into log books
  • Review manufacturing documentation real time to ensure compliance
  • Coordinate sample preparation and testing
  • Propose and review document revisions
  • Carry out work in a safe manner, notifying management of safety issues and risks

15% This individual will manage equipment and support facility related projects by:

  • Initiating work orders
  • Act as subject matter expert for improvement projects
  • Perform scheduled cleaning of equipment
  • Assembly and disassembly of process equipment
  • Perform standardization of equipment
  • Support change over activities
  • Execution of equipment and process qualifications and validation

15% Working with supervision this individual will:

  • Provide technical training for area personnel
  • Provide input on training material development
  • Meet and maintain training requirements
  • Develop and maintain personal development plan
  • Provide annual performance self assessment

Education and Experience Requirements:

  • Normally requires a high school diploma and 4-6 years related industry experience or an Associates Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience
  • Biotech Certificate preferred

Key Skills, Abilities, and Competencies

  • Substantial understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered.
  • Will be required to perform as a subject matter expert for equipment and/or systems
  • The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
  • Possess excellent communication and troubleshooting skills.
  • Full awareness of current Good Manufacturing Practices.
  • Proficient computer skills.
  • Proficient in Aseptic Technique
  • Ability to work cohesively in a team environment
  • Experience with business systems such as ERP, LIMs, and Trackwise

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 -

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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