At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

Engineering Project Support and Operation Readiness:

• Act as the Facility & Utility Engineer representative on the project team contributing to design construction and qualification activities. This includes reviewing URS (User Requirement Specification) and executing FAT SAT and IOPQ to contribute to project delivery.
• Lead or act as facility and utility maintenance team coordinating with Engineering department production department quality department vendors etc for cooperation to achieve the positive goal.
• Establish and develop facility and utility maintenance operation system in alignment with the Roche standards including maintenance management system people training and qualification CCS strategy and implementation to support robust operation readiness.
• Support manager to develop a competent team through coaching mentoring and training by having in place a skill competencies development and appraisal program to strengthen the technical expertise and capabilities.
• Participate in tech transfer collaboration with other functions to ensure the success of new product manufacturing.
• Represents the facility and utility during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.

Routine Operation & Maintenance:

• System Ownership:

• Take full accountability for the operation and maintenance of Facility & Utility systems ensuring all activities comply with Roches GMP/EHS standards and regulatory guidelines.
• Work as a Sterilization aseptic expert to provide technical support in Facility & Utility aspects.
• On call for system emergent complex trouble shooting escalated from technicians.
• Ensure that all relevant information relating to activities within your scope is tracked captured and forwarded in due time to your manager or the head of department.
• Establish and maintain a strategic and technical roadmap for the responsible area to support the sites strategic development and product lifecycle.

• Maintenance Execution:

• Plan and execute preventive and corrective maintenance programs to maximize equipment availability and optimize life-cycle costs.
• Enhance Facility & Utility system maintenance and operation through implementation of an effective maintenance and operation program work prioritization complying with operational and personnel standards regulatory and statutory requirement to ensure efficient reliable and uninterrupted plant operation.
• Propose spare parts for responsible equipment and control the cost within budget.

• Compliance:

• Ensure audit readiness by adhering to cGMP regulatory and statutory requirements to protect product quality and prevent compliance observations.
• Represent the Facility & Utility systems during regulatory inspections and audits.
• Responsible for the Quality and Accuracy of data and records of relevant equipment and maintenance.

• Troubleshooting & Improvement:

• Respond to critical alarms lead deviation investigations execute CAPAs PE and provide timely technical support for complex issues.
• Drive continuous improvement initiatives to enhance sustainability safety and asset reliability.
• Ensure in time response to critical alarms in compliance with the SOP and related Quality Procedures.
• Evaluate the alarm trends and establish corrective actions to avoid repeat events.

• Assets Lifecycle Management & Reliability:

• Evaluate the system capacity and provide related Operational & Maintenance data for project initiation.
• As the Facility & Utility system owner and SME actively participate in the design review comment commissioning and handover of site new projects according to Site CAPEX process.
• Responsible for the implementation of the site Reliability Engineering process within owned areas.

• Sustainability: Support to drive continuous improvement by providing recommendations and initiative to promote sustainability (Energy & Water) safety maximizing asset reliability and operational performance to drive operation excellence in utilities operation to achieve financial objectives to gain cost competitiveness.
• Documentation: Maintain accurate and timely records of all equipment and maintenance data. Draft and/or review SOPs and other relevant documentation.

Qualification and Experience

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.