Shire Capital Projects Engineering Manager in Thousand Oaks, California

Summary

The Capital Projects Engineering Manager is recognized within Shire as a subject matter expert (SME) for the Thousand Oaks Biologics manufacturing facility with respect to all Capital portfolio management and project delivery activities. In this role, he / she is responsible all capital program and project activities within the Site Engineering function.

This position reports into the Head of Site Engineering at the Thousand Oaks manufacturing site. The Capital Projects Manager is an integral member of the Site Engineering Leadership Team. He / she also interacts closely with the Operational Managers within the Site OLT and PMO office at the facility to ensure that all capital projects are delivered to support reliable and robust manufacturing operations.

The Capital Projects Manager ensures that the Capital Projects team is staffed with the appropriate skills and capabilities to meet all Site Engineering functional goals. He / she establishes an efficient capital delivery organization focusing on right first time delivery and following industry best practices to meet the strategic needs of the Shire Thousand Oaks Manufacturing Plant. He / she also ensures that all capital projects result in fit for purpose assets which meet the business requirements (safety, functionality, capacity, capability, maintainability, compliance and reliability) in a timely and cost effective manner

Lastly he / she ensures that adequate technical and numerical support is provided to the capital projects team to assure the success of all capital projects under his / her control.

Essential Duties and Responsibilities

  • Lead, resource as appropriate and manage the Capital Projects portfolio of works associated with the Shire Thousand Oaks manufacturing facility (hereafter ‘the facility’)

  • Initiate and lead the long range planning activities (including AIMP - re-capitalization process requirements) for all capital projects associated with the facility and review / amend as necessary to meet the current, emerging and future business needs

  • Consult with site stakeholders to ensure their current and future capital needs are identified and defined.

  • Challenge the site stakeholders potential capital needs with respect to their value and alignment with the business goals

  • Establish capital project program and establish mechanisms to ensure that the projects are prioritized against the business goals

  • Consult and coordinate with above site stakeholders to gain alignment on the facility capital needs in terms of value, timelines and criticality to the business (compliance, continuity, effectiveness and profitability)

  • Lead the initial planning of potential capital projects (feasibility / concept stage) ensuring that user business and functional requirements are identified, challenged and clarified to ensure that a robust business charter can be defined and approved by the key stakeholders

  • Create and align as necessary the execution structure and delivery models for capital projects (both GMP related and non GMP related) reflecting their size, complexity and criticality to the business need.

  • Deploy industry best practices (Front End Loading, stage gate reviews, VIPs etc.) to increase outcome predictability and mitigate schedule and cost over run

  • Coordinate the planning, monitoring and reporting of all capital projects associated with the facility

  • Lead the preparation and review of all capital appropriation requests before submission to Head of Site Engineering and the SLT for approval

  • Fulfill all relevant compliance, safety and quality requirements by focusing on right first time principles and using compliance as a competitive advantage

  • Fulfill all legal and EHS requirements as they relate to capital projects, permitting and approvals

  • 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

  • Lead the risk management process for capital projects including the creation and periodic refresh and monitoring of risk registers and associated mitigation, escalation and communication activities

  • Hire as necessary contingent professionals needed to define, plan and execute the portfolio of capital projects as necessary

  • Train and develop the capital projects team to make sure that they can fulfill all of their assigned goals and contribute to the achievement of the capital project delivery success and Site Engineering Department goals and KPIs

  • Prepare and update the assigned Capital Projects operational budgets and fulfillment of the budget targets

  • Consult and seek alignment with the other engineering site functions to ensure that the most appropriate technical specifications, standards and practices are incorporated into the design basis

  • Manage the resource loading of the capital projects portfolio providing adequate visibility of needs to all stakeholders and providing development opportunities for site based staff as appropriate

  • Consult and seek alignment with the Engineering Operations, Plant Engineering, Process Engineering and Automation functions within Site Engineering to achieve the optimal engineering structure and effectiveness of services delivered to the Manufacturing Plant

  • Consult and seek alignment with the site engineering functions to ensure that the appropriate technical deliverables are provided in a timely manner and format so that they can be transferred into the lifecycle management systems (CMMS, CCMS etc.)

  • Consult and coordinate with Capital Projects representatives within Global Engineering to share lessons learned and best practices

  • Represent the Engineering Capital Project function in all internal and external audits

  • Adhere to any applicable EHS, Regulatory and corporate requirements.

  • Commit to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.

  • Stakeholder for the engineering documentation management. Oversee contracted CAD services, keeping control and organized inventory of engineering drawing system.

  • Carry out any other duties as assigned by supervisor.

Qualifications

  • A strong leader capable of providing leadership to teams of Engineers and end users

  • Proven capital project delivery experience in a GMP environment (preferably Bio-pharma)

  • Thorough knowledge of capital project delivery models and best practices

  • Planning capability (MS Project) highly desirable

  • Strong interpersonal skills and communication abilities. Able to manage up and across the organization

  • Business acumen

  • Project Controls and financials experience

Education and/or experience

  • Min. Degree holder in Engineering discipline with >10 years working experience in engineering with considerable exposure to capital project delivery

  • Experience in Manufacturing and Pharmaceuticals capital projects (Bio-pharma preferred)

  • Leadership experience> 5 years managerial experience within engineering and manufacturing team, leading technical and professional resources.

  • Thorough knowledge of current Good Manufacturing Practices (cGMP)

Notice to Employment / Recruitment Agents:

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Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.