DP 21-GMP运营工程师

1. 01

   Production Management Prepare filling station before production (e.g., size part change, equipment setup, isolator glove integrity test, material loading, leak test, VHP execution, SCADA batch setup). Perform filling operations (aseptic assembly, sterile filtration, equipment operation, IPC sampling, data entry). Complete post-production tasks (remove residual materials, collect waste, clean equipment). Maintain 5S and participate in other production activities.

2. 02

   Document Control Draft, update, and train SOPs; maintain MBR templates per GMP

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3. 03

   Equipment Management Perform routine maintenance (calibration, component replacement). Support equipment qualification and manage status labeling. Handle equipment movement and introduction of new equipment.

4. 04

   Quality Events Draft and implement changes; investigate deviations; write risk assessments. Track deviation status and ensure compliance with procedures.

5. 05

   Audit Support Present audit topics, respond to auditor questions, and prepare findings responses.

6. 06

   New Facility Projects Participate in expansion project discussions and decisions. Coordinate training for new production equipment.

7. 07

   EHS Responsibilities Lead safety audits and promote safety culture. Participate in risk assessments and investigate safety/environmental incidents. Requirments: Education: Bachelor’s degree or above in Pharmaceutical Science, Microbiology, Biological/Chemical Engineering, or related field. Skills & Competencies: Strong problem-solving and analytical ability. Excellent communication and coordination skills. Detail-oriented, organized, and team-oriented. Technical Abilities: Proficient in document writing and computer software. Ability to manage documentation and maintain accurate records.