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The Position

1.  Primary Purpose of Job (Job Summary)

The Equipment Maintenance Manager is responsible for managing, maintaining, and optimizing equipment on site, including formulation, filling, packaging, QC lab etc., ensuring efficient, controllable, and compliant production processes. Also provides support during the project and startup phase and liaise with the engineering firm on the design/construction/qualification of the equipment, ensuring they meet the intended standard and quality requirements.

This is a people leader position. Strong skills and experience are required to cover two areas: Greenfield project delivery and Routine Operation.

●           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 all equipment design, qualification, operation readiness and start up.

●           The role will ensure close collaboration with the site and project organization to ensure Roche business goals, responsible for the following activities: 1) Process equipment including formulation, filling line, package line supporting equipment; 2) QC lab equipment; 3) Warehouse equipment, 4) Production shop floor support. etc.

●           Also provide training to site users to ensure the operational use, and shop floor service during production.

●           Responsible for implementing site equipment management according to Roche global strategy.

2.  Principle Roles & Responsibilities / Accountabilities

Leadership & People Management

●           Possesses strong creative leadership competencies and integrates Leadership Commitments into daily practices. Demonstrates the ability to cultivate a forward-thinking outlook, remove barriers, develop people's skills and technical capabilities, and create an environment that empowers individuals to perform at their best.

●           Build and retain an inclusive workforce and foster an environment where diversity of thought and perspective are valued.

●           Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

●           Take the responsibility for daily SHE management, implement site SHE procedure and program, and achieve site corporate /site SHE KPI. Promote SHE culture and improve employee safety behavior.

●           Lead, coach, and guide the organization. Manage team members’ performance and development to achieve organizational goals and employee personal and professional growth.

●           Build a strong pipeline of talent and robust succession plans for key positions.

●           Maintain a culture of continuous improvement and model lean leadership principles.

●           Maintain a culture of transparent, high performance, empowerment and innovation culture.

Technical

Engineering Project Support and Operation Readiness:

●           Play the role of equipment representative to contribute on project design, construction and qualification, including but not limited to specifying, sourcing, installation and qualification etc. to contribution on project delivery.

●           Establish and develop site equipment in alignment with the Roche standards.

●           Assist the Engineering head to set up team and people hiring schedule to build a competitive team that meets the project and production ramp up plan.

●           Develop a competent team through coaching, mentoring and training by having in place a skill competencies development and appraisal program to strengthen technical expertise and capabilities.

●           Represents the equipment during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.

Routine Operation

●           As the equipment owner, accountable for the operation and maintenance of production and lab equipment, manages the relevant maintenance with Roche’s GMP/EHS standards and regulatory guidelines. Enhance production and QC lab 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.

●           Responsible for Planning of maintenance activities with various departments to ensure resources, parts and vendors are on site per schedule for maintenance work. Execute preventive and corrective maintenance programs and specific maintenance plans for production and QC lab assets that maximize equipment availability and to optimize life-cycle costs.

●           Ensure audit readiness by complying with effective standards, regulatory/statutory and cGMP requirement to protect products and to prevent major compliance observation.

●           Responsible for the Quality and Accuracy of data and records of relevant equipment and maintenance.

●           Involve in the deviation investigation and CAPA execution, including appropriate escalation where needed to ensure closure within the set timeline.

●           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.

●           Ensure that all relevant information relating to activities within your scope are tracked, captured and forwarded in due time to your manager or the head of department

●           Draft and/or review SOPs, project and validation activities …in place in the company.

●           Follow Roche standards: record all activities accurately and on time, report all events that are not aligned with the SOP.

●           Apply incident, CAPA and change control processes.

●           Work as a Sterilization aseptic expert to provide technical support in the filling area.

●           Propose spare parts for responsible equipment and control the cost within budget.

3.  Qualification and Experience

Education/Qualifications

●           Bachelor's degree or above in Mechanical Engineering, Electrical Engineering, Automation, Biopharmaceutical Engineering, or a related field.

●           PMP preferred.

●           Familiarity with relevant local regulations and authorities (e.g., NMPA).

Job Required Competencies

●           15 or more years’ equipment maintenance experience in the injection pharmaceutical industry, MNC Bio-pharma preferred.

●           5 or more years’ people management experience, with VACC (Visionary, Architect, Coach, Catalyst) leadership established

●           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 operation management system.

●           Expertise:

•        Technical & Equipment Knowledge: Mechanical Systems, Electrical Systems, Automation & Control.

•        Maintenance Strategies: Predictive Maintenance (PdM), Condition based Maintenance (CbM), Preventive Maintenance (PM), Root Cause Analysis (RCA).

•        CMMS (Computerized Maintenance Management System).

●           Able to think strategically and translate strategies into actionable plans, understands and apply agile ways of working.

●           Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.