Manufacturing Engineer

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.