职位描述
职位职能:
??医药技术研发人员??
职位描述:
JOB TITLE: Industrialization Engineer (PPM)
Location: Shanghai
1. PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Responsible to guaranty the new products/processes transfer to production, to provide technical support and/or improvements to existing products/processes, and to participate in change control process for manufacturing.
？(1) Provide technical lead for new culture media transfer for site production activities, change control to existing products/processes and troubleshooting (culture media contamination, wrong aspect of media); including scale-up and/or automating production processes in order to increase capacity or reduce production costs.
？(2) Create and present reports on conducted experiments (microbiological analytical performance, microbiological results interpretation, operating in sterilized condition), product transfer and validation lots, failure investigations and troubleshooting. Create and revise the necessary documentation to implement into production, including ERP data. Assure the documentation is compliant to company and Regulatory guidelines.
？(3) Participate in Project Meeting to present reports and the status of the work package he/she is responsible for.
？(4) Use knowledge of techniques and methods such as Project Management, Risk Analysis. (e.g. FMEA), Problem Solving Methods (e.g. Lean 6 Sigma).
？(5) Coordinate parallel projects involving other departments and assure effective communication.
？(6) Other tasks as defined in related company procedure, or assigned by hierarchic superior.
2. KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
？(1) BS with a > 5 years’ experience in Industrialization or MS with 2 years’ experience in Industrialization, Manufacturing or Microbiological labs.
？(2) Team player mindset.
？(3) Quick learner and eager to learn.
Education & Knowledge:
？(1) Microbiology/bacteriology background.
？(2) Knowledge of Risk Analysis, Problem Solving, current Good Manufacturing Practices,statistical methods, Analytical skills.
？(3) Knowledge of site product lines and manufacturing processes including QC PPM.
？(4) Fluent English both written and oral.
