Principal Commissioning & Qualification Engineer

Job description

·  Job facts

Purpose

Global Engineering executes major CAPEX projects in the Pharma Division with focus mainly on Pharma Technical Operations (PT). TheSenior C&Q Engineer / Principal C&Q Engineerprovides discipline focused project management, technical leadership and accountability forCommissioning & Qualification Engineeringin 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/Tasks

TheSenior C&Q Engineer / Principal C&Q Engineerhasadvancedskills in the follow Project Management focus areas.

·  Acts as Sub-Project Manager forCommissioning & Qualification Engineeringwith personal responsibility for:
·  Applying decision making processes
·  Defining roles and responsibilities
·  Gaining alignment with key stakeholders, customers and project management team
·  Management of sub-Project to approved budget and schedule
·  Definition of priorities
·  Close coordination across disciplines
·  Regular status updates including progress vs plan, risks, mitigations

Including substantial contributions to overall project scope including:

·  Options Analysis
·  Project Planning
·  Execution strategies
·  Development of detailed Schedule based on Work Breakdown Structure
·  Resourcing
·  Estimating
·  Executes 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 addressed
·  Partners 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 facilities
·  Planning 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 units
·  Perform the role of Business Process Manager within one of the C&Q Community of Practices
·  Act as certified reviewer for discipline reviews for CAPEX Projects
·  Is an acknowledged expert within Roche
·  Mentor and coach less experienced engineers
·  Work 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 / Experience

·  Bachelors Degree inEngineeringor related discipline with12to15years of experience preferable in pharmaceutical/biopharmaceutical ,10to13years of experience with Masters Degree,7to10years of experience with PhD
·  Preferred Requirements:MSinEngineeringand/or an MBA
·  10years of experience in international management of capital projects
·  Able to execute scope that is complex on projects that are mid-sized to large

Knowledge/Skills/Competencies

·  Excellentcollaboration, teambuilding and communication skills
·  Strong 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 management
·  Embodies Roche Values and Leadership Commitments
·  Significant travel such as assignment requiring weekly commuting or temporary remote assignment as required to meet the business need
·  International project assignment of 1 to 3 years as required to meet the business needs

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·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.