灭菌/配液工程师-Chengdu

1. 01

   Production Activity Management Execute manufacturing activities (lyophilization, vial washing, sterilization, formulation, etc.). Clean and maintain Grade C/D equipment and facilities; support validation activities. Manage equipment movement, status labeling, and 5S in C/D areas. Coordinate production resources (e.g., water, steam).

2. 02

   Document Management Draft and revise GMP-compliant documents. Check, organize, and review production records and logbooks. Prepare URS for the area.

3. 03

   Quality Events (Deviation/Change/CAPA/Risk Assessment) Draft and implement changes; investigate deviations; write risk assessments. Track deviation status, organize discussions, and collect feedback.

4. 04

   Audit Support Assist with on-site coordination during audits. Organize responses to findings and related tasks (meetings, issue tracking).

5. 05

   EHS Responsibilities Lead safety audits and promote safety culture. Participate in risk assessments and incident investigations.

6. 06

   Personnel Training & Development Plan and organize GMP/EHS training. Allocate work based on qualifications; track training and operator skills.

7. 07

   Other Tasks Manage disinfectant recovery and distribution. Coordinate EM sampling in C/D areas. Support continuous improvement projects to enhance efficiency. Requirements 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.

教育背景（Education） 药学、微生物学、生物工程、化学工程或相关专业本科及以上学历。 技能与胜任力（Skills & Competencies） 具备较强的问题解决能力和分析能力。 具备优秀的沟通协调能力。 工作细致严谨，组织能力强，具有团队合作精神。 专业技能（Technical Abilities） 熟练掌握文件编写及常用办公软件。 具备良好的文件管理能力，能够确保记录的准确性和完整性。 具备一定的英文听说读写能力，能够接待国内外客户现场参观及工艺介绍