Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-MA, Single Use Engineer Manager SR0033270-MZ


 
 

Primary Duties

Single Use Engineer Manager will have a key role towards the successful design, implementation and deployment of sound business processes for the Lexington site operations. He/she performs work independently and in alignment with pre-defined goals and business objectives, will help the organization realize its vision for the future, and will have the potential to become an expert in the field.

He/she will:

Work in alignment with best practice methodology and industry standards, per regulatory and compliance, for the design of business processes that may include electronic system implementations, Participate and lead discussions to collect and define current and future process workflows, Champion single-use process and program harmonization across the Massachusetts biologics organization (MBO) and act as an ambassador of the site s single-use solutions with other sites throughout the organization. Gain knowledge and apply previous experience to define user requirements and system configurations, Coordinate validation and deployment/implementation activities, and Maintain new systems, processes, or materials introduced to sustain process improvements Own, support and facilitate changes and improvements through quality systems such as Change Controls, Corrective and Preventative Actions (CAPAs), Supplier Notifications of Change, Engineering Change Management. Support use and/or maintenance of manufacturing technology systems such as Simca, Infor, Statistica, PI historian, etc.

Responsibilities

50%

Participate in the implementation, improvement and deployment of manufacturing processes/systems. Provide expertise and guidance to implementation of new single-use technologies and work with stakeholders to improve and streamline the process of single-use implementation and use. He/she will coordinate workshops and provide inputs as part of feasibility/front end studies, detailed system design, product technology transfers and project implementations.

25%

In alignment with the objectives of the Biologics Ops Unit of Technical Operations and the Massachusetts Biologics Operation, participate in ongoing efforts ensuring timely completion of tasks. Act as an operation s SME and spokesperson, providing process overviews and inputs from the process perspective, while ensuring that the deliverables meet the business needs of the manufacturing organization. Interact with cross-functional teams including but not limited to Manufacturing, Facilities and Engineering, Quality, Validation, Operational Excellence & Training, Supply Chain and Technical support teams (Process Development and Manufacturing) and Tech Ops to collect, analyze and describe relevant information, per business priorities and established data strategy.

25%

Train on relevant industry standards for systems, learn Takeda s Biologics manufacturing and business operations (end-to-end), attend and present at industry conferences on relevant manufacturing systems and processes and become familiar with the current and future systems landscape.

Mentor and train junior team members.

Education and Experience Requirements

  • Bachelor s degree in Biotechnology, engineering or related field. Advanced studies, post graduate degrees or specialty training courses are desirable
  • Minimum of 7 - 10 years of combined experience in manufacturing operations and systems implementations and/or use. Previous direct involvement in manufacturing of biologics, pharmaceuticals or devices, either in manufacturing operations or technical floor support is preferred
  • Additional experience in the implementation, validation and/or use of GMP compliant systems such as Trackwise, Statistical Systems (Statistica, Simca), LIMS, ERP, Manufacturing Execution Systems (MES), floor automation or data analysis tools is highly desirable
  • Experience with Single-Use Technologies, including but not limited to a general understanding of current solutions offered within the industry (Bag assemblies, mixing technologies, transfers set), the suppliers and sub-suppliers providing materials, an understanding of component capabilities and how to implement single-use technologies is highly desirable.

Other Job Requirements

  • Occasionally, it may be necessary to travel to: Takeda locations to attend business meetings (less than 10% time) and professional trainings or industry conferences.

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.