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The Position
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, CHT, SHT etc. to contribute to project delivery.
Support the initial development and optimization of logistic processes.
Participate in the implementation of operation readiness, e.g. draft equipment operation procedures and logbook, 5S, machine cleaning according to readiness plan.
Trained and qualified on equipment operation and procedure.
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. facility cleaning, cleanroom garments preparation, cleaning and sterilization of components.
Train new employees and enhance the professional capabilities of the team.
Handle deviations during production and implement CAPA.
Diagnose and resolve equipment malfunctions promptly with the support of maintenance engineers to minimize downtime.
Support regular validation activities, such as autoclave requalification.
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 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.
Compensation & Benefits
This position also offers an attractive benefits package .
Learn more about how we reward our employees at Roche.
Roche · Shanghai, China