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Principal Commissioning & Qualification Engineer

Company: Hoffmann-La Roche Ltd
Location: oceanside
Posted on: May 3, 2021

Job Description:

Global Engineering executes major CAPEX projects in the Pharma Division with focus mainly on Pharma Technical Operations (PT). The Principal Commissioning & Qualification Engineer provides discipline focused project management, technical leadership and accountability for C&Q of facilities and systems in the delivery of capital projects and engineering services to support PT manufacturing, CMOs, and Affiliates. This includes projects that are single and multidisciplinary in nature. The Principal C&Q Engineer reports to the Resource Manager (Head of Project Engineering and Execution) within the region.Key Sub-Project Management Responsibilities/TasksThe Principal C&Q Engineer has advanced skills in the following Project Management focus areas.Acts as Sub-Project Manager for Commissioning & Qualification Engineering with personal responsibility for:o Applying decision making processeso Defining roles and responsibilitieso Gaining alignment with key stakeholders, customers and project management teamo Management of sub-Project to approved budget and scheduleo Definition of prioritieso Close coordination across disciplineso Regular status updates including progress vs plan, risks, mitigationsIncluding substantial contributions to overall project scope including:o Options Analysiso Project Planningo Execution strategieso Development of detailed Schedule based on Work Breakdown Structureo Resourcingo EstimatingExecutes deliverables in compliance with Engineering Manual, Global Standards and Processes and all other Roche Guidelines and DirectivesExpresses 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 attitudeChallenges the status-quo and develops creative solutions within the framework of Global Standards and ProcessesLeads proactive measures to achieve the specified goals in the event of deviations from the project planManages a sub-project team including external contractors and gives clear guidance to the team in terms of technical solutions and/or business processesMaintain ownership of assigned work-package within discipline through all project phases so that target functionality, quality and reliability are achievedDiscipline SpecificsExtensive experience in the application of risk-based validation (RBV) and ASTM E2500 within the following manufacturing areas: biologics drug substance, biologics drug product, utilities and facilitiesExperience in the Commissioning & Qualification of emerging manufacturing technologies such as single-use systems, individualized therapies preferedPlanning 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 manages work activities of others.Qualifications: required educations / experiences / competenciesEducation / ExperienceBachelor's Degree in Engineering or related discipline with 12 to 15 years of experience preferably 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 MBA10 years of experience in international management of capital projectsAble to execute mid to large sized complex projects (C&Q Scope $5M-20M)Knowledge/Skills/CompetenciesExcellent collaboration, teambuilding and communication skillsStrong business and technical acumen, strategic agility and global perspective necessary to lead the groups to world-class performanceGlobal 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 as required to meet the business need. Temporary remote assignment may be required depending on business need.#LI-CA1#ptcareers

Keywords: Hoffmann-La Roche Ltd, Oceanside , Principal Commissioning & Qualification Engineer, Other , oceanside, California

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