Posted to MedZilla on 5/22/2019

Takeda Pharmaceuticals

US-CA, Sr. Process Engineer II SR0034567-MZ


Plans, executes and functionally directs Process Engineering assignments and projects, which require sound engineering skills and independent judgment. Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products or processes.

Essential Duties and Responsibilities

  • Manage large and complex capital and operational projects with moderate supervision to achieve critical project targets. Effectively manage project risks and utilize project management methodology.
  • Lead Pharma Bulk & Fractionation equipment improvement projects. Implement equipment and process control system changes following established change control standards. Develop detailed commissioning plans and provide technical input to validation documents as needed.
  • Contribute to the development of improved and robust control strategies for Manufacturing processes in Pharma Bulk & Fractionation.
  • Support B8 bulk manufacture, B5 Fractionation and Process Engineering System Owner concept for processes and relevant processes and products. Responsible for equipment operating efficiencies and uptime through the system owner concept.
  • Develop strong business case of new, continuous improvement projects including the economic evaluation of technically feasible alternatives. Must have a clear understanding of the business strategic objectives and the roles within.
  • Create detailed and accurate capital and operational project schedules and budgets. Interface and align with cross functional groups. Responsible and accountable for project due dates and costs. Identify and resolve issues that may jeopardize project schedules or improve project time.
  • Develop solution to complex technical problems that require the regular use of ingenuity, creativity and innovation. Represent the organization as the prime technical contact on projects.
  • Establish, develop and drive Good Engineering Practices and conduct projects according to the prescribed Project Management Methodology.
  • Provide mentoring to engineers and technicians as needed, and manage contractors on projects.


  • Strong process engineering skills based on sound engineering and scientific principles.
  • Extensive technical expertise and strong working knowledge of other related disciplines of engineering common to Bioscience business.
  • Must have excellent communication skills in order to effectively communicate with all level of professionals. Both internal and external.
  • Demonstrated ability to write reports clearly, describing results from complex processes and qualifications.
  • Able to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Must be self-motivated , have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
  • Effective team member with experience in handling multiple projects and leading cross-functional teams with minimal guidance.
  • Able to prioritize multiple tasks and incorporate cGMP, change control requirements and safety into designs.
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.

Education and/or experience

  • Bachelor s Degree in Chemical, Mechanical or Bio-Chemical/Bio-Pharmaceutical Engineering.
  • Minimum 10 years of experience in process design, engineering and process improvement.
  • Scope requires an in-depth knowledge of pharmaceutical, chemical or food industry process equipment related to process equipment, and general working GMP knowledge of pharmaceutical manufacturing facilities and all major utilities.

Physical Demands

  • Must be able to lift, push, pull and carry up to 25 lbs.
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold, wet environment
  • Must be able to work multiple shifts, including weekends.
  • Must be able to work overtime as required. (only for non-exempt positions)
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.

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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