Head of Facility and Engineering

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The Position

Roche is hiring for an expanding operation in Shanghai and is seeking to expand its site leadership team, with growing Drug Product operations. We are looking for people who have significant experience in Sterile Drug Product operations, in a leadership position, who can bring investments through qualification and into steady state operations. These are new roles in Roche and we are looking for

Dynamic leaders who can set up operations, whilst also displaying strong people leadership skills to create and grow new teams. Previous expertise ( 10 years ) in sterile pharmaceutical manufacturing operations, where work takes place in a highly automated environment and having a site leadership position whilst operating in a regulated, China and overseas regulatory environment is an advantage.

• Enable and empower your team to deliver our vision through demonstrating VACC (Visionary, Architect, Coach, Catalyst) leadership behaviors and focusing on strategic project development in China
• The role plays a critical part in strategic project realization including facility design, qualification and manufacturing readiness and start up
• The role will assumes accountability of the routine operations. Overall responsible for the smooth and efficient running of the site with Roche’s goal & strategy，in full compliance and consistency with GMP/ EHS requirements and Roche’s corporate principles, quality policies and standards
• The role will ensure a close collaboration/engagement with the global organization / global manufacturing network
• Be part of the Site Leadership Team and report to the Site Head, will lead the following functions: (1) Engineering Services (2) Lifecycle Management and Maintenance (3) Process Controls; including Process Equipment Engineering, Validation, Value Stream Support, and Technical Services (4) Operational Technology/Automation
  
  
  

Principle Roles & Responsibilities / Accountabilities
Leadership & People Management

• Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward -thinking outlook; remove barriers, develop people and technical capabilities; build an environment which enables people to perform at their best
• Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion
• Build and maintain strong partnerships with network leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships
• Lead, coach, and guide the team. Manage performance and develop team members to achieve organizational goals and employee personal and professional growth
• Take the responsibility for daily EHS management, Promote EHS culture and improve employee safety behavior
• Build a culture of continuous improvement and operational excellence.
• Build a strong pipeline of talent and robust succession plans for key positions
• Create open, transparent, caring and safe working environment in accordance with company culture
  
  

Engineering Project Support and Operation Readiness:

• Plays the role of F&E representative to contribute on project design, construction and qualification
• Establish appropriate project URS including facilities/utilities and process equipment according to process requirement
• Support PQ activities such HVAC PQ, APS etc. to contribution on project delivery
• Ensure all the equipment and systems fulfill the GMP quality requirements, ensure the reliability of the equipment and systems by correct understanding, controlling and monitoring, also maintain all of the equipment, facilities and utilities in full operational level to fully match the requirement of production/test
• Setup team organization structure and people hiring schedule to build a competitive team that meets the project and production ramp up plan
• Establish and develop the engineering operation system in alignment with the Roche standards including maintenance and calibration management system, people training and qualification, sterility assurance program, CCS strategy and implementation
• Define and implement spare parts lifecycle strategy including the requirement, supplier selection, inventory and replacement management
  
  

Routine operation：

• Ensuring and end-to-end oversight of the validated and qualified status of the assets, processes and embedded systems of the value streams over the entire life cycle
• Support production and project teams in all questions of plant engineering, maintenance, automation and utilities
• Working as plant engineering lead in Site Capital investment projects for building and commissioning of the manufacturing units. Main responsible for delivering all input required for utilities
• Continuously examining and developing processes and procedures for optimization potential as part of efficiency/technology improvement measures
• Continuously monitor budget target and implement control measures, make suggestions for cost optimization and savings
• Communicate with the global technical support and relative teams to ensure that operational requirements meet global requirements, share experience with global to leverage the same practice
  
  
  

Qualification And Experience
Education/Qualifications

• Bachelors Degree (science or engineering is preferred) and above
• PMP certificate is preferred
  
  
  

Job Required Competencies

• 12 or more years’ F&E and Maintenance or related experience in the pharmaceutical industry, MNC Bio-pharma preferred
• 6 or more years’ people management experience
• Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification
• Experienced in new facility startup readiness and operation ramp up including organization, people and maintenance management system
• Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological and vaccine industry
• Assets lifecycle management knowledge of GMP facility & Utility and production equipment
• Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
• Good assertiveness in a global environment and a continuous approach to improvement
• Proven ability to coach and implement lean ways of working Strong creative leadership skills according to the Visionary, Architect, Coach, Catalyst (VACC) model
• Fluent communications skills in English and the ability to effectively communicate and influence across all levels of the organization
  
  

Who we are

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.

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.