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The Position

Roche is hiring for a greenfield facility in Shanghai and we are looking for senior process equipment engineer, for who overall accountability to maintenance relevant equipment/systems to reliably support production and QC lab activities. Also provides supports during the project, operation readiness and start-up phase and liaise with the engineering firm on the design/construction/qualification of the production area and QC lab, ensuring they meet the intended standard and quality requirements.
This is a Senior SE position. Strong skill 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 process equipment, supporting equipment and Lab equipment design, qualification and operation readiness and start up.
•    The role will ensure a 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) Production shop floor support. etc.

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 departmentDraft 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 processesWork as Sterilization aseptic expert to provide the technic support in filling areaPropose spare parts for responsible equipment and control the cost within budget;

Qualification and Experience

Bachelor’s Degree (Mechanic, Electrical, or Engineering is preferred) and aboveSpecial Equipment management certification8 or more years’ facility & utility management, engineering experience in the injection pharmaceutical industry, MNC Bio-pharma preferredPeople management experience preferredExperienced in strategic project of Aseptic Filling facility including design, commissioning & qualificationExperienced in new facility startup readiness and operation ramp up including organization, people and operation management systemStrong 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 workingFluent 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.