Posted to MedZilla on 4/25/2019

Takeda Pharmaceuticals

US-CA, Process Engineering Manager SR0033202-MZ


The Engineering manager is recognized within Takeda as a subject matter expert (SME) and lead with respect to all Engineering activities at one of the Rancho Manufacturing Facility platforms in Thousand Oaks. In this role, he / she is responsible to provide the necessary managerial and technical expertise with regards to equipment, Systems, Process Automation and Reliability Engineering activities within the Site Engineering function.

This position reports into the Head of Site Engineering at the Thousand Oaks manufacturing site. The Engineering Manager is an integral member of the TO Site Engineering Leadership Team. He/she also interacts closely with the Operational Managers within the Site OLT to ensure that all engineering activities are delivered to support reliable, compliant, maintained and robust manufacturing operations.

The Engineering Manager ensures that the reporting engineering team is staffed with the appropriate skills and capabilities to meet all Site Engineering functional goals. He / she establishes the engineering organization focusing on right first time delivery and following industry best practices to meet the strategic needs . He / she also ensures that all engineering activities result in fit for purpose assets which meet the business requirements (safety, functionality, capacity, capability, reliability, properly maintained and in compliance) in a timely and cost effective manner.

Lastly he / she ensures that adequate technical and numerical support is provided to the Engineering Operations team to assure the success of engineering operations aspects of improvement projects.

  • Lead, resource as appropriate and manage the portfolio of works associated with the Engineering function (Manufacturing System Engineering system owners, and Process controls / Automation engineering).
  • Provide the necessary leadership to drive and maintain the engineering operations and technical support for the engineering team as appropriate.
  • Provide the necessary technical engineering support to manufacturing systems to ensure that all manufacturing systems are available and fit for intended purpose.
  • Fully accountable of all the assets performance, reliability, safety and compliance.
  • Partner with other functions to provide the necessary Maintenance Excellence and Reliability Engineering expertise with respect to Process and infrastructure equipment including Mechanical, Electrical, Instrumentation Engineering Disciplines to establish, maintain and amend as necessary technical specifications and standards to ensure the ongoing reliability of installed assets at the site
  • Fulfill all relevant external and internal compliance, EHS and quality requirements by focusing on right first time principles and using compliance as a competitive advantage
  • Hire and train the workforce as necessary for the Site Engineering function.
  • Develop the plant engineering team to make sure that all reports can fulfill their assigned functional goals and KPIs and contribute to the achievement of the overall Site Engineering Department goals and KPIs
  • Build a performance oriented culture with a focus on the Takeda Leader Behaviors, Continuous Improvement and Right First Time
  • Lead and coordinate the Quality Event process for Site Engineering and ensure timely creation, analysis and closure of events assigned to Site Engineering with special focus on achieving the BOLT Quality KPIs
  • Manage out of hours emergency / urgent response from plant engineering team
  • Liaise with the Manufacturing Teams and all Support Groups to ensure the fulfillment of production targets and operational effectiveness
  • Ensure the continuous improvement of all processes and workflows to promote a right first time culture and yield stable, lean and efficient manufacturing and business processes as well as an efficient and lean organization
  • Execute selection and manage service contractors and suppliers ensure right services, competency level, cost and fulfillment to relevant Quality, EHS, Finance, regulatory policy and requirement
  • Develop and maintain SOPs for site utility systems, equipment maintenance strategies and maintenance tasks for all site equipment fulfilling all Regulatory Requirements and EHS Policies
  • Provide technical expertise to enable rapid trouble shooting and in depth investigations relating to and equipment failure and mal-operation to maintain and improve asset availability and reliability
  • Provide the necessary technical expertise to ensure that all engineering master data is identified and maintained in an appropriate and compliant fashion. Maintain the technical drawings and records to ensure that the as built status of the facilities is maintained and administer the changes to the engineering records and data in a timely manner.
  • Monitor and report relevant metrics to measure plant performance e.g. utility availabilities, maintenance costs
  • Create and maintain appropriate training standards, guides and material for Engineering
  • Manage assigned projects within the engineering function and support other departments at site in the planning and execution of projects
  • Provide technical support for projects within engineering and other departments in the planning and execution of projects
  • Ensure that operation and maintenance procedure / activities are established and maintained in alignment with all Quality & EHS Systems and Policies, Legal & Regulatory Requirements
  • Prepare, update and manage the assigned engineering department cost center budgets and fulfillment of the budget targets
  • Liaise with the Manufacturing Teams and all Support Groups to ensure the fulfillment of all plant goals
  • Consult and seek alignment with the other Engineering Operations, to achieve the optimal engineering structure and effectiveness of services delivered to the Manufacturing Plant
  • Consult and coordinate with within Global Engineering to share lessons learned and best practices
  • Liaise with global engineering functions to provide feedback on proposed and existing engineering standards and implement these as appropriate within the facility
  • Represent the Engineering Function in all internal and external audits
  • Adhere to EHS requirements e.g. job risk assessment, observance of permit-to-work system
  • Commit to a fair and respectful relationship to others and behavior in accordance with Takeda s Code of Conduct
  • Carry out any other duties as assigned by supervisor.

  • Strong interpersonal skills and communication abilities. Able to manage up and across the organization
  • Leadership experience; good people management skill
  • Excellent in systematic trouble shooting and problem solving skill
  • Good writing skills essential for investigations, reports and proposals
  • Business acumen

  • Min. Diploma in a relevant Engineering Discipline - preferred
  • >10 years hands-on equipment maintenance and utilities experience in a cGMP manufacturing environment
  • > 5 years managerial experience within engineering and manufacturing team, leading technical and professional resources.
  • Excellent experience in Equipment maintenance and reliability Program
  • Must have technical knowledge and experience in plant maintenance and facilities management
  • Thorough knowledge of current Good Manufacturing Practices (cGMP)
  • Experience leading teams in a process, automations, maintenance/reliability function and utilities operation

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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