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Principal Commissioning & Qualification Engineer

Company: Genentech
Location: Vacaville
Posted on: May 7, 2020

Job Description:

Purpose-- -- -- -- --Global Engineering executes major CAPEX projects in the Pharma Division with focus mainly on Pharma Technical Operations (PT).-- The Senior C&Q Engineer / Principal C&Q Engineer provides discipline focused project management, technical leadership and accountability for Commissioning & Qualification Engineering in the delivery of capital projects and engineering services to support PT, CMO, and Affiliates.-- This includes projects that are single and multidisciplinary in nature.--Key Sub-Project Management Responsibilities/TasksThe Senior C&Q Engineer / Principal C&Q Engineer has advanced skills in the follow Project Management focus areas.Acts as Sub-Project Manager for Commissioning & Qualification Engineering with personal responsibility for:Applying decision making processesDefining roles and responsibilitiesGaining alignment with key stakeholders, customers and project management teamManagement of sub-Project to approved budget and scheduleDefinition of prioritiesClose coordination across disciplinesRegular status updates including progress vs plan, risks, mitigationsIncluding substantial contributions to overall project scope including:Options AnalysisProject PlanningExecution strategiesDevelopment of detailed Schedule based on Work Breakdown StructureResourcingEstimatingExecutes deliverables in compliance with EM, Global Standards and Processes and all other Roche Guidelines and Directives----Expresses relevant information timely, clearly and concisely to relevant stakeholders including adjusting communication style to the audience being addressedPartners proactively with key customers, team members and stakeholders, while being open and approachable with a friendly, positive and professional attitude-- -- -- -- ----Challenges the status-quo and develops creative solutions within the framework of Global Standards and Processes-- -- -- --Leads proactive measures to achieve the specified goals in the event of deviations from the project plan-- -- -- -- -- --Manages a sub-project team including external contractors and gives clear guidance to the team in terms of technical solutions and/or business processes-- -- -- ----Maintain ownership of assigned work-package within discipline through all project phases so that target functionality, quality and reliability are achieved-- --Discipline Specifics--Extensive experience include systems and equipment within the following areas: biologics drug substance,-- biologics drug product, small molecules drug substance, small molecules drug product, packaging/warehousing, GMP & Non-GMP utilities and facilitiesPlanning and Execution of Projects: Systems & Equipment C&Q strategies, C&Q document development and execution, including PQS/EM compliance and establishing collaborative working relationships with Quality unitsPerform the role of Business Process Manager within one of the C&Q Community of PracticesAct as certified reviewer for discipline reviews for CAPEX ProjectsIs an acknowledged expert within RocheMentor and coach less experienced engineersWork is largely self directed, and exercises considerable latitude in determining objectives and approaches to assignments.-- Provides guidance and manage work activities of others.Qualifications: required educations / experiences / competencies-- -- -- --Education / ExperienceBachelors Degree in Engineering or related discipline with 12 to 15 years of experience preferable in pharmaceutical/biopharmaceutical , 10 to 13 years of experience with Masters Degree, 7 to 10 years of experience with PhDPreferred Requirements: MS in Engineering and/or an MBA-- --10 years of experience in international management of capital projectsAble to execute scope that is complex on projects that are mid-sized to largeKnowledge/Skills/Competencies-- --Excellent collaboration, teambuilding and communication skillsStrong business and technical acumen, strategic agility and global perspective necessary to lead the groups to world-class performance-- ----Global experience and culturally savvy, can adapt to and effectively manage in various cultural environments and organizational levels including executive managementEmbodies Roche Values and Leadership CommitmentsSignificant travel such as assignment requiring weekly commuting or temporary remote assignment as required to meet the business needInternational project assignment of 1 to 3 years as required to meet the business needs

Keywords: Genentech, Vacaville , Principal Commissioning & Qualification Engineer, Engineering , Vacaville, California

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