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The PositionPrimary Purpose of Job (Job Summary)
Organize and coordinate the works assigned to his/her in the functional sectionAssure safety, GEP (Good Engineering Practice), and cGMP (current Good Manufacturing Practice) compliance within his/her responsible area and workplaceProvide efficient and cost effective utility supply and engineering maintenance servicesSet up and improve facilities management systemPrinciple Roles & Responsibilities / Accountabilities (Major functions of the position)
Responsible system:
GMP related Facilities & Utilities, such as, HVAC, BAS/BMS, clean room, ambient room, cool room, cold room, freezing room, air locker, Purified Water, Compressed Air and etc.Responsibilities will include:
Responsibilities to include hands-on involvement with the troubleshooting, maintenance and operation of above-mentioned system. Set up maintenance task, plan for these systems and coordinate year planned shut down for facility maintenance.Evaluation of responsible equipment and system’s performance through assessment of equipment and system logs, monitoring reports, and maintenance program. Develop corrective measures to improve equipment operational efficiency.Provide technical assistance to site operating groups through investigations, equipment assessments, and design support.Develop and update equipment/systems preventative maintenance plan, and order components/parts according maintenance plan.Perform and manage the maintenance contract and manage the service provider.Management of building and utility control systems to ensure response to critical alarms in compliance with Maintenance and Quality Procedures. Evaluate trends and establish corrective actions to avoid repeat events.Participate in the review of responsible equipment and system’s design, changes including specification and drawing reviews.Responsible for the development and implementation of GMP Facilities & Utilities system instrument calibration plan, room temperature and humidity, pressure difference calibration plan, air volume balance testing, environmental monitoring, etc.Safety, Health & Environment:
Ensure that all applicable Safety, Health & Environment requirements are compliant to group policy and local legal requirements.Quality and Compliance:
Collaborate with site quality to make sure Right to operate through compliant to all related regulatory requirements.Implement and apply the Roche Pharma Quality System.General Customer Service:
Identify the customers that are the recipient of the service delivered.Develop effective relationships with key customers in order to understand their business and expectations.Deliver services according to established service level agreements.Seek feedback from customers and/or stakeholders on performance and ability to meet expectations.Incorporate feedback:Takes accountability to balance customer expectations and value for Roche.Takes ownership for problem resolution and escalates as appropriate.Response to customer is timely and communication is efficient.Qualification and Experience
Education/Qualifications:
Have a bachelor degree in HVAC, machinery or automation (equivalent or higher), and must have more than 2 years of facility technical service experience in the pharmaceutical industry.English proficiency: Proficient in using English in writing work documentsLeadership Competencies:
Must have excellent organizational, coordination, communication, teamwork skills.Job Required Competencies:
Technical knowledge regarding the operation, preventative maintenance and trouble-shooting of site utilities is required.Must have demonstrated ability to solve certain technical problems and ability to work independently.Experience in equipment commissioning programs is required.Solid experience with manufacturing industry and support equipment is essential; working knowledge of process control systems is required.Must have excellent organizational, communication and personal work management.Who we areAt 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 China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roche's third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients’ unmet needs.
Roche is an Equal Opportunity Employer.