Posted to MedZilla on 8/17/2019

Takeda Pharmaceuticals

US-GA, Principal Production Engineer III - Albumin & Fractionation SR0033239-MZ


The Principal Production Engineer Albumin & Fractionation is responsible for support of the Albumin and Fractionation departments in Covington, GA. The position utilizes engineering and project management skills to align processes and teams to resolve complex manufacturing problems. The position focuses on accelerating the timeline to achieve full production rate by accelerating change.

Primary responsibilities of this role include:

  • Defining and implementing roadmap for Manufacturing Execution System (MES) optimization
  • Reducing manufacturing challenges through ownership of departmental issue and delay logs and the resulting improvement initiatives
  • Supporting ramp-up and steady-state operations of two highly-automated pharmaceutical manufacturing facilities. Scope of support will include:
    • Plasma Fractionation and Albumin Purification processes
    • Manufacturing Execution System (Siemens Simatic IT)
    • Distributed Control System (DeltaV) and Process Logic Controllers
    • Process equipment (vessels, centrifuges, filter presses, UF/DF, robotics, COP washers, CIP skids)
    • Automation hardware
    • In Process Testing lab (pH, conductivity, titration)
    • Safety and quality investigations
  • Continuously improving manufacturing operations by:
    • Reducing manufacturing events, user interventions, and batch record alerts
    • Identifying opportunities and delivering projects to reduce cycle time, error proof operations, and eliminate waste
    • Performing operational assessments to ensure proper processes, procedures, tools, and training are in place
    • Developing Manufacturing Unit (MU) initiatives and leading Continuous Improvement efforts
  • Training, coaching, and mentoring on-shift Production Engineers
  • Actively supporting information sharing and learning between team members by:
    • Leading Knowledge Transfer training with manufacturing and engineering staff
    • Coaching manufacturing staff while partnering with them to resolve technical issues
    • Developing troubleshooting guides for common problems
    • Sharing process knowledge with colleagues across-shift


  • B.S. degree in an engineering or scientific discipline (Chemical or Mechanical Engineering preferred)
  • Minimum of 5 years of related work experience, preferably within a GMP environment
  • Experience with engineering principles in various engineering disciplines
  • Ability to solve complex engineering problems with minimal assistance
  • Ability to discuss complex technical and project management issues, both verbally and in written form
  • Ability to lead cross-functional teams, influence, and work as a collaborative team member
  • Self-driven individual that requires minimal supervision
  • Training and demonstration of concepts of Lean Manufacturing and Six Sigma quality techniques is preferred
  • Ability to flex work schedule and take call as required to support manufacturing operations and project needs
  • Ability to work in a clean room environment
  • Ability to wear personal protective equipment (such as hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas
  • Ability to travel on an infrequent basis (< 5 %)

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.

Please visit our website at


* 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.