Shire Capital Projects Engineering Manager in Thousand Oaks, California
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.
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
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)
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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.