Project Manager IV

Oceanside, California 92056 | Contract

Post Date: 02/20/2018 Job ID: 3910 Industry: Project Management

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They  are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

This position has overall responsibility for leading complex small capital projects or programs to successful completion. Responsible for effective project management of all major project phases: initiation, design, procurement, construction, commissioning, qualification and closeout.   Assures that the capital investment is able to achieve functional, strategic, compliance and financial goals.   Requires excellent internal and external collaboration and influencing skills and the ability to lead diverse, crossfunctional teams in the successful delivery of projects. Typical project/program size ranges from $500k - $10M. Work is self-directed.

 

Duties:
  • Responsible for leading small capital and expense projects for Project Delivery (PD). Accountable for achieving project goals related to cost, schedule and scope.  
  • Ensures that capital delivery methodologies, project management processes/principles and project management tools are consistently utilized to achieve project goals. Complies with Roche Quality policies and U.S. Pharma Code of Conduct.
  • Responsibilities include day-to-day project coordination, project management of project design and execution according to cost, schedule, quality, safety and customer satisfaction objectives, while ensuring compliance with local laws, technical rules and regulations.  
  • Ensures project planning and execution adheres to Engineering Manual Lite (EM Lite) requirements, project management processes and principles. Ensures that project management tools are consistently utilized to achieve project goals and objectives and to deliver successful projects.  
  • Ability to collaborate with end-user and create clear user requirement specifications.
  • Lead in the development of the project engineering plan and help coordinate review by relevant functions.
  • Run regular project team meetings, issue meeting agendas and minutes; maintain action item, change and lessons learned logs. 
  • Develop project schedule and monitor progress against baseline timeline, communicate schedule variances and critical path.
  • Makes project related scope, cost and schedule decisions in consultation as appropriate with project stakeholders and PD staff.  
  • Perform risk assessments.   Escalate risks to PD and stakeholders, create mitigation plans.
  • Effectively communicates with and influences all levels of the organization. Exercises excellent judgment in determining appropriate project communications to internal and external stakeholders.
  • Provides regular project status updates and presentations for senior management and the broader organization.
  • Partners proactively with key customers and stakeholders (Manufacturing, MTS, Automation, Engineering, Facilities, Quality and Validation) to develop and execute capital projects that support business objectives. 
  • Partners proactively with other groups/functions (Finance, Procurement, Informatics, SHE, Planning, Legal, etc.) to meet project objectives, adhere to business processes impacting project planning/execution, and to implement business process changes.
  • Provides strong project team leadership and champions project team collaboration. Influences and negotiates with project team members and project stakeholders to gain alignment and win concessions without damaging relationships.
  •   Ensure proper project documentation deliverables are identified and completed per project scope.   
  • Create and maintain organized project file systems for each project.  
  • Provide routine and ad hoc project status and performance information regarding assigned projects, including monthly project reports
  • Ensure project cost control and inform others on funding requirements.   Review commitments and expenditure for goods and services, including contractor, subcontractor, supplier, and consultant selection, as well as approval and control of any commitments charged to the project, including contracts, purchase orders, invoices, fees, travelling costs and expenses
  • Keep key project customers, partners and other stakeholders aware of critical issues as these arise and seek assistance as necessary
  • Develop project design flow based on specifics of project type, i.e. process, utility, automation
  • Ensure appropriate consulting and provision of the necessary approvals of technical experts, such as engineering, quality, environmental, health and safety, technology, etc.
  • Support knowledge exchange within PD.   Participate in lessons learned workshops during and after handover of projects and integrate relevant input from previous projects
  • Drives and promotes a culture of project management excellence in the organization. Supports continuous improvement of project delivery practices.
  • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’ s functional area.   Fosters a positive safety culture in which no one gets hurt.
  • Perform work in compliance with current Good Manufacturing Practice (cGMP) requirements and Roche corporate standards.
  • Ensures assigned training requirements are current

 

Education and Experience  
  • B.S. in Engineering (Chemical, Mechanical, Electrical preferred), Science or equivalent is required.
  • Minimum of 8 years experience successfully managing projects in the biotech/pharmaceutical industry.  
  • Certification in project management (i.e. PMP certification) is highly desirable.  
  • Experience with capital projects, project controls, and project scheduling.
  • Experience from a background of manufacturing, design or construction.
  • Strong working knowledge of Microsoft based programs

 

Knowledge, Skills and Abilities
  • Exceptional leadership, interpersonal, communication, negotiation, collaboration, and management skills.  
  • Proven expertise in applying and/or developing advanced project management tools and methodologies. Must understand the basic principles of various engineering disciplines.  
  • Understands facility end user operational needs and principles. Understands and is advocate for end-user organizations to assure that the project meets or exceeds all compliance requirements and functional needs.  
  • Strong technical leadership, collaboration, and sound business value based prioritization and problem solving skills. Excellent interpersonal, leadership and conflict resolution skills will be required, as the role works frequently in a resource challenged and schedule sensitive environment.
  • Excellent communication and presentation skills with the ability to effectively communicate ideas, goals, and results to various audiences. Must deliver effective presentations to senior management.
  • General knowledge requirements include all applicable building codes and related regulations, basic design and construction methodologies, (particularly in the process and mechanical discipline) and expertise in project management practices (including finance, risk management and control systems), EH&S regulations, Quality Assurance and IT systems.  
  • Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus a solid understanding of cGMP requirements.
  • Good understanding of clean room or classified area design/requirements.
  • Familiarity with biopharmaceutical manufacturing, process equipment and supporting utility systems, especially those related to sanitary and sterile operations.
  • Familiarity with biopharmaceutical process operation and process control.
  • Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.
  • Knowledge of process, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation. 
  • Demonstrate strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner.
  • Ability to review engineering drawings and specifications.
  • Excellent organization and time utilization skills.
  • Use creativity and innovation to address urgent and/or complex problems and propose solutions.
  • Fluent written and verbal English (proficiency in additional languages is a plus) 

Education and Experience  

  • B.S. in Engineering (Chemical, Mechanical, Electrical preferred), Science or equivalent is required.
  • Minimum of 8 years experience successfully managing projects in the biotech/pharmaceutical industry.  
  • Certification in project management (i.e. PMP certification) is highly desirable.  
  • Experience with capital projects, project controls, and project scheduling.
  • Experience from a background of manufacturing, design or construction.
  • Strong working knowledge of Microsoft based programs

 

Knowledge, Skills and Abilities

  • Exceptional leadership, interpersonal, communication, negotiation, collaboration, and management skills.  
  • Proven expertise in applying and/or developing advanced project management tools and methodologies. Must understand the basic principles of various engineering disciplines.  
  • Understands facility end user operational needs and principles. Understands and is advocate for end-user organizations to assure that the project meets or exceeds all compliance requirements and functional needs.  
  • Strong technical leadership, collaboration, and sound business value based prioritization and problem solving skills. Excellent interpersonal, leadership and conflict resolution skills will be required, as the role works frequently in a resource challenged and schedule sensitive environment.
  • Excellent communication and presentation skills with the ability to effectively communicate ideas, goals, and results to various audiences. Must deliver effective presentations to senior management.
  • General knowledge requirements include all applicable building codes and related regulations, basic design and construction methodologies, (particularly in the process and mechanical discipline) and expertise in project management practices (including finance, risk management and control systems), EH&S regulations, Quality Assurance and IT systems.  
  • Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus a solid understanding of cGMP requirements.
  • Good understanding of clean room or classified area design/requirements.
  • Familiarity with biopharmaceutical manufacturing, process equipment and supporting utility systems, especially those related to sanitary and sterile operations.
  • Familiarity with biopharmaceutical process operation and process control.
  • Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.
  • Knowledge of process, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation. 
  • Demonstrate strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner.
  • Ability to review engineering drawings and specifications.
  • Excellent organization and time utilization skills.
  • Use creativity and innovation to address urgent and/or complex problems and propose solutions.
  • Fluent written and verbal English (proficiency in additional languages is a plus) 
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