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Principal Commissioning & Qualification Engineer

Company: Hoffmann-La Roche Ltd
Location: Hillsboro
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/Tasks

The 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 processes

o Defining roles and responsibilities

o Gaining alignment with key stakeholders, customers and project management team

o Management of sub-Project to approved budget and schedule

o Definition of priorities

o Close coordination across disciplines

o Regular status updates including progress vs plan, risks, mitigations

Including substantial contributions to overall project scope including:

o Options Analysis

o Project Planning

o Execution strategies

o Development of detailed Schedule based on Work Breakdown Structure

o Resourcing

o Estimating

Executes deliverables in compliance with Engineering Manual, 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 in the application of risk-based validation (RBV) and ASTM E2500 within the following manufacturing areas: biologics drug substance, biologics drug product, utilities and facilities

Experience in the Commissioning & Qualification of emerging manufacturing technologies such as single-use systems, individualized therapies prefered

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 manages work activities of others.

Qualifications: required educations / experiences / competencies

Education / Experience

Bachelor'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 PhD

Preferred Requirements: MS in Engineering and/or an MBA

10 years of experience in international management of capital projects

Able to execute mid to large sized complex projects (C&Q Scope $5M-20M)


Excellent collaboration, 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 as required to meet the business need. Temporary remote assignment may be required depending on business need.



Keywords: Hoffmann-La Roche Ltd, Hillsboro , Principal Commissioning & Qualification Engineer, Other , Hillsboro, Oregon

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