康龙化成(宁波)新药技术有限公司

企业性质:私营/民营企业 所属行业:制药/医疗-制药/生物工程 公司规模:200-500

Technology Transfer and Process Validation Engineer

职位要求

工作性质:全职 工作地点:慈溪市-杭州湾新区 发布日期:2019-12-18
工作经验:3-5年 学历要求:本科 职位月薪:面议
所属行业:生物/制药/医疗器械-生物工程/生物制药 招聘人数:2 性别要求:不限

任职要求

1.Desired Skills
1.1.Knowledge in Process development ﹠ pilot plant operations
1.2.Experienced in hazard assessment for Intermediates/API’s from the bench scale to full scale manufacturing, including handling exothermic reactions, Thermal Stability for chemicals, Thermal hazard of synthesis (Calorimetric techniques)
1.3.Basic understanding of cGMP, Design of experiments and modeling, Risk assessment

2.Candidate (requirements)
2.1.BS/MS in Chemical engineering from an accredited university.
2.2.2-5 years of experience in Pharmaceutical industry in R﹠D domain and pilot plant operations.
2.3.Strong written and oral communication skills
2.4.Working knowledge i6395E3741ED1FAFC9027CC52B1341DCB9B7CBB94F72CCD0622D57C7DE1171D7AC20A4F421AFAF4E58038AAD3CB9A379F786F4284EB0951D1n English is preferable.

岗位要求

Role ﹠ Responsibilities
1.Responsible planning and implementation of late stage project Technology Transfer.
2.Responsible for organizing and leading risk assessment meeting by using advanced method, e.g. FMEA. Providing the input on process feasibility evaluation, analyzing the operational feasibility at plant Scale, process safety assessment based on plant scale, cGMP practices, and material management during risk assessment.
3.Responsible for preparation of6395E3741ED1FAFC9027CC52B1341DCB9B7CBB94F72CCD0622D57C7DE1171D7AC20A4F421AFAF4E58038AAD3CB9A379F786F4284EB0951D1 technology transfer documents including, internal transfer plan, risk assessment reports, qualification protocols, process justification reports technology transfer reports, BPR, process flow chart, PFD etc.
4.Executive action which is given from risk assessment, including experiments, equipment improvement with support from maintenance team etc.
5.Provide engineering calculation by using Dynochem and available PE lab support.
6.Collect and analyze production data in order to identify improvement opportunities include Throughput, Productivity, Overall Plant Effectiveness, Quality, yield etc., and improve the plant utilization with optimal planning and De-bottlenecking.
7.Provide implementation on new technology in the system for improving the process efficiency and cost reduction.
8.Identification of critical process /stage/operation for technology development and dynamics etc.,)
9.Participate in the implementation of the action plans when CAPA are required and implement in timely manner.

联系方式

联 系 人:方小姐

手    机:0574-56330181

邮    箱:ya.fangpharmaron-bj.com

邮    编:315336

地    址:宁波杭州湾新区生命科技园


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