Additional Information
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The Position
1. Primary Purpose of Job (Job Summary)
Roche is hiring for a greenfield facility in Shanghai, and we are looking for a Packaging Engineer, with strong execution skills and hand-on experiences in packaging operation and techniques, who has mastery of core packaging processes and the capability to operate and maintain packaging equipment to ensure production continuity and reliability. Additionally, who will collaborate closely with the project team to execute this strategic initiative-including facility design, qualification, manufacturing readiness and start-up activities.
The Packaging Engineer is responsible for achieving manufacturing goals within the process step i.e. Needle cutting,labeling and Packaging. Ensuring products are executed safely and timely in full compliance and consistency with GMP/ SHE requirements and Roche's corporate principles, quality policies and standards.
Be responsible for the operation and cleaning of related process equipment on the packaging line including needle cutting, labeling, cartoning, T&T, shipping case machine and palletizing machine.
Be responsible for packaging materials handling including the needles inspection on the packaging line.
Support to perform equipment qualification and process validation on the packaging line.
Support Associate Manager to complete equipment operation training and procedure training on the packaging line.
Be responsible for documentation revision and deviation/CAPA/Planned Event writing.
2. 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 etc. to contribute to project delivery.
Support the initial development and optimization of packaging processes.
Draft equipment operation procedures and logbook according to operation readiness plan.
Train and qualify operators on equipment operation and packaging techniques and CCS implementation in packaging., e.g Needle Cutting and Visual Check, Labelling and Packaging.
Perform other duties as assigned.
Routine Operation:
Ensure routine operation in compliance with Roche's GMP/SHE and regulation requirements.
Performing the following tasks: Needle Cutting and Visual Check, labelling and packaging.
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.
Execute regular validation activities.
Related IT system operations, such as SAP, MES, Veeva, Cornerstone.
Perform other duties as assigned.
3. 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 project of packaging facility including design, commissioning & qualification is preferred.
Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in 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