- Location
- SHANGHAI, China
- Type
- Full-time
- Department
- Engineering
- Seniority
- Senior
- Source
- Workday
Description
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
Qualification and Experience 能力与经验
Education/Qualifications
Bachelor’s Degree (Mechanic, Electrical, or Engineering is preferred) and above
Special Equipment management certification
Job Required Competencies
8 or more years’ facility & utility management, engineering experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
People management experience preferred
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
Strong knowledge on operation and maintenance of drug product process equipment, especially aseptic process experience.
Able to think strategically and translate strategies into actionable plans, understands and applies 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.
Engineering Project Support and Operation Readiness:
- Play the role of process equipment representative to contribute on project design, construction and qualification, including but not limited design, equipment selection, URS review, FAT, SAT, IOPQ to contribution on project delivery.
- Lead filling and packaging maintenance team coordinate with Engineering department, production department, quality department, vendors, etc for cooperation to achieve the positive goal.
- Establish and develop the production and lab equipment 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 function to ensure the success of new product manufacturing.
- Represents the process equipment during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.
Routine Operation:
- As the system owner, accountable for the operation and maintenance of production and lab equipment, manage 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 product 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 recommendation and initiative to promote sustainability (Energy & Water), safety, maximize 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 Sterilization aseptic expert to provide the technic support in filling area
Propose spare parts for responsible equipment and control the cost within budget;
Qualification and Experience
Education/Qualifications
Bachelor’s Degree (Mechanic, Electrical, or Engineering is preferred) and above
Special Equipment management certification
Job Required Competencies
8 or more years’ facility & utility management, engineering experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
People management experience preferred
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
Strong knowledge on operation and maintenance of drug product process equipment, especially aseptic process experience.
Able to think strategically and translate strategies into actionable plans, understands and applies 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.
