锦鲤求职岗位描述
在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。
职位
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.
我们是谁
打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。
让我们一起，构建更健康的未来。
罗氏提供平等的职业发展机会。