Posted to MedZilla on 9/18/2019

Takeda Pharmaceuticals

US-GA, Manager, Production Engineering - Albumin & Fractionation SR0040735-MZ


The Production Engineering Manager will oversee technical support for ramp-up and steady-state commercial manufacturing operations within the Albumin and Fractionation departments at Takeda in Covington, GA. This includes day-to-day engineering and troubleshooting for the manufacturing process, automation, and equipment. The Production Engineering Manager leads a team of approximately 12 engineers that provide 24/7 on-site support.


  • Manage and direct the work of approximately 12 on-shift Production Engineers in providing leadership, technical support, and real-time decision making in the following areas:
    • Plasma Fractionation and Albumin Purification processes
    • Process equipment (vessels, centrifuges, filter presses, UF/DF, robotics, COP washers, CIP skids)
    • Distributed Control System (DeltaV) and Process Logic Controllers
    • Manufacturing Execution System (Simatic IT)
    • Automation hardware
    • In Process Testing lab (pH, conductivity, titration)
    • Process management
    • Safety and quality investigations

  • Develop the Production Engineering team into customer-oriented, manufacturing experts capable of providing operational ownership of unit operations, engineering assessments for change control and event investigations, as well as technical representation for regulatory and safety agencies

  • Drive continuous improvement within the manufacturing organization with specific focus on:
    • 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, and training are in place
    • Developing Manufacturing Unit Team initiatives and leading Continuous Improvement efforts

  • Create a learning culture within the manufacturing organization that fosters team development through:
    • 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 all shifts

  • Provide systems to ensure consistent business performance by:
    • Committing to employee feedback and developmental processes
    • Defining and maintaining team metrics which drive improved business results
    • Assisting the department heads to meet the annual operating plan, budgetary commitments, and continuous improvement initiatives
    • Preparing budgets and forecasts for areas of responsibility
    • Assuring compliance to all regulatory requirements FDA, OSHA, EPA, etc.
    • Maintaining environmental, health, safety, and quality performance
    • Supporting plant-wide strategic plan programs and activities


  • Bachelor s degree from an accredited institution in an engineering or scientific discipline with a minimum of 8 years of experience within the pharmaceutical, biotechnology, or comparable environment
  • Demonstrated record of successful execution within a manufacturing environment, success within an FDA regulated environment is highly preferred
  • Advanced supervisory and leadership skills, including demonstrated ability to coach, provide feedback, and develop both teams and individuals
  • Excellent technical and troubleshooting skills
  • Working knowledge of core engineering principles in various disciplines (chemical, mechanical), unit operations (precipitation, centrifugation, filtration, UFDF, CIP, COP, robotics), support systems (WFI, RO, clean steam, HVAC), and facility design
  • Ability to make independent decisions a
  • Ability to lead cross-functional teams, exert broad influence, and work as a collaborative team member
  • Ability to communicate effectively across the organization both verbally and in written form
  • Ability to provide 24/7 on-call support and work overtime as required
  • Ability to perform a combination of activities including both office and manufacturing tasks
  • Ability to work in controlled environments with gowning restrictions including protective clothing covering the head, face, hands, feet, and body; no make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment
  • Ability to work in a loud area that requires hearing protection and other protective equipment
  • Ability to travel up to 10 %

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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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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