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Purpose  

Global Engineering executes projects in Pharma Technical Operations (PT), and other divisions within Roche on demand. Within Global Engineering, the Commissioning & Qualification (C&Q) Engineer has overall responsibility for the compliant, in time and in budget delivery of Commissioning & Qualification deliverables.  The Commissioning & Qualification Engineer reports to the PTT Head of C&Q, but may also be part of a regional reporting structure. Work is self-directed in nature. Projects / initiatives can vary in both length of time and complexity, requiring extensive cross-functional collaboration and agile execution strategies in support of GMP manufacturing operations, affiliates and CMOs. The position requires excellent internal and external collaboration and influencing skills and the ability to lead diverse, cross-functional teams.   

This is a 100% full time role and preference is for locally based candidates 

Key Responsibilities/Tasks

The Commissioning & Qualification Engineer has proficient skills in the following Project Management focus areas.

Acts as Sub-Project Manager for Commissioning & Qualification Engineering with responsibility for:

Leading cross-functional project teams in the C&Q phase with engaged team members through building and leading teams, motivates and inspires the team members, setting clear expectations for team members, strong communication skills and clear decision-making. 

Driving alignment with key stakeholders, customers and project management team, close coordination across disciplines

Defining clear roles and responsibilities, definition of priorities

Management of C&Q project scope to approved budget and schedule

Regular status updates including progress vs plan, resource demand and schedule update, risks, mitigations

Substantial contributions to overall project scope including:

Options Analysis

Project Planning

Execution strategies

Development of detailed Schedule based on Work Breakdown Structure

Resourcing incl. bid packages and supporting procurement activities

Estimating

Supporting handover

Executes deliverables in compliance with internal Project management procedures (Engineering Manual)

Comply with Roche Pharmaceutical Quality Management System (PQS), Global Standards and Processes 

Comply with Roche Pharma Code of Conduct and all other Roche Policies and Directives.

Ensure adherence to local laws and applicable technical rules and regulations.

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

Onboard and manages the C&Q team including external contractors and gives clear guidance to the team in terms of technical solutions and/or business processes, set clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met.

Ensure deployment and management of an effective (Contractor) safety program, meeting Roche requirements and metrics/KPI’s throughout the C&Q project lifecycle.

Ensure training of self is always current and all team members are trained as appropriate for their role.

Maintain ownership of assigned work-package within discipline through all project phases so that target functionality, quality and reliability are achieved

Within the framework of Global Standards and Processes, effectively and constructively challenge the status quo, within and beyond Roche and Global Engineering, identifying better ways to accomplish department and program objectives.

Introduce innovation and best practices for C&Q Capex project management, to project team, peers and customers/stakeholders.  

Proactively build trustful and effective relationships with key customers and stakeholders, and partner pro-actively to develop and execute (assigned Capex Project) to support Roche business objectives.

Qualifications (education/experience/knowledge/skills/competencies)

Education & Experience

University Degree in Engineering, Science or related discipline with 10 or more years of experience preferable in pharmaceutical/biopharmaceutical industry

Experience in management of capital projects

Working experience in Manufacturing, Qualification / Validation / Engineering or related areas at a sterile drug product manufacturing site

Able to execute scope that is complex on projects that are mid to large-sized

Knowledge/Skills/Competencies

Excellent collaboration, teambuilding and communication skills

Understands facility end user operational needs and principals.  Understands and is an advocate for End-User organizations to assure that the project meets or exceeds all compliance requirements and functional needs. Ability to create a collaborative “one team” environment.

Vast experience in the Commissioning, Qualification and Validation including systems and equipment within the following areas: sterile drug product manufacturing, packaging/warehousing, GMP & Non-GMP utilities and facilities, automation systems

Planning and Execution of Projects: Systems & Equipment C&Q strategies / ASTM E2500, risk based approach, C&Q document development and execution, application of industry standards and best practices and establishing collaborative working relationships with Quality partners

In-depth pharmaceutical knowledge, global regulations and industry standards (Chinese regulations, FDA, EMA, ICH,…) 

Proven expertise in effectively applying and/or developing advanced project management tools and methodologies

Track record of having the courage to drive change, while balancing risks and pacing for success.

In addition, you bring the following competences and skills:

Global experience and culturally savvy, can adapt to and effectively navigate in various cultural environments and organizational levels including executive management.

Proficient knowledge of Mandarin and English (written & spoken)  

Travel (20%) may be required to meet the business need, in order to lead the team at the project site/location. Expectation if assigned to a specific project during design or construction the candidate will spend most of their time on site

National and/or International project assignments of 1 to 3 years may be required to meet the business needs.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.