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Principle Roles & Responsibilities / Accountabilities
Engineering Project Support and Operation Readiness:
● Participate in new facility design and construction, including but not limited to process design, FAT, SAT, IOPQ, smoke study, VHP, Isolator EMPQ, APS etc. to contribute to project delivery.
● Support the initial development and optimization of aseptic filling processes.
● Participate in the implementation of operation readiness, eg: draft equipment operation procedures and logbook, 5S, machine cleaning according to readiness plan.
● Trained and qualified on equipment operation and aseptic techniques.
● Perform other duties as assigned.
Routine Operation:
● Ensure routine operation in compliance with Roche’s GMP/SHE and regulation requirements.
● Performing the following tasks: e.g. vial washing, filling and stoppering, capping.
● Train new employees and enhance the professional capabilities of the team.
● Support environmental monitoring activities to ensure that the Isolatore environment meets aseptic standards.
● Handle deviations during production and implement CAPA.
● Diagnose and resolve equipment malfunctions promptly with the support of maintenance engineers to minimize downtime.
● Execute regular validation activities, such as APS.
● Ensure data accuracy, integrity, and traceability for the activities in the GMP area.
● Related IT system operations, such as SAP, MES, Veeva, Cornerstone.
● Perform other duties as assigned.
Qualification and Experience
Education/Qualifications
● College’s Degree (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies
● 5 or more years’ operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred.
● Experienced in strategic projects of Aseptic Filling facility including design, commissioning & qualification，Isolator filling line is preferred.
● Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.
● Fluent communications skills in English is preferred and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
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.