Pharmaceutical Project Instrument R&D Engineer

Job Responsibilities

1. Responsible for verifying the GLP compliance of R&D instruments and designing specific management requirements that meet documentation/risk control requirements based on instrument software/hardware conditions;

2. Lead, support, promote, follow up or execute the account, authority, audit trail, time verification, data backup and restore, instrument method, output report and exception handling required by documentation;

3. Lead, support, promote, follow up or execute risk management for instrument URS, additions, acceptance, IOP, qualification plans, calibration plans, repair, maintenance, borrowing, transfer and retirement;

4. Periodically implement the above knowledge, experience and updated management requirements in the form of training;

5. Manage the sorting, organizing and administration of instrument spare parts and consumables;

Qualifications

1. Associate degree or above in a science or engineering related field;

2. Understand the requirements of GLP, GMP and registration-related regulations for instruments/data, and have a thorough understanding of risk identification, analysis and control of data integrity in R&D operations;

3. 2+ years of experience in the use/management of analytical instruments (documentation, software/hardware, data, etc.) in pharmaceutical companies;

4. English proficiency: able to accurately read and understand instrument and equipment related materials;

5. Good time management and self-management skills, with a strong sense of responsibility and principle;

6. Strong communication/execution skills with a results-oriented work style;

7. Adaptable to short-term business trips as required by work.

Work Location

China/Jiangsu

Department

Headquarters R&D Department