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醫(yī)藥中間體化學(xué)合成車間工藝工程師

7000-10000元
  • 大連
  • 3-5年
  • 本科
  • 全職
  • 招1人

職位描述

化工產(chǎn)品研發(fā)化學(xué)分析
Job Purpose (State briefly the overall objective of the job)
Responsible for the technical management of chemical processes assigned to him/her under supervision. Supports the scale-up/commercial production and coaches production people in matrix organization. Ensure deliveries, HSE, GMP targets for his/her processes..
負(fù)責(zé)所賦予化學(xué)工藝的技術(shù)管理，支持放大和商業(yè)化生產(chǎn)并指導(dǎo)培訓(xùn)生產(chǎn)人員，保證所負(fù)責(zé)工藝HSE GMP目標(biāo)的實(shí)現(xiàn)和各種交付。
Basic Major Activities (Describe main activities)
1. Point of contact for process support for manufacturing， Consult with process chemist in R&D, prepare and execute master batch record.
作為生產(chǎn)工藝支持的主要聯(lián)系人，和研發(fā)化學(xué)師協(xié)商,完善和執(zhí)行車間主批記錄。
2. Plan, organize & prepare equipment trains, raw materials and other production factors (e.g. mass balance sheet, PFD, Hazard analysis, coordinate IPC with R&D) for manufacturing of intermediates and drug substances
計(jì)劃，組織和準(zhǔn)備設(shè)備反應(yīng)鏈，反應(yīng)原料和其他原料藥中間體及原料藥生產(chǎn)相關(guān)因素（例如準(zhǔn)備物料平衡圖，工藝流程圖，風(fēng)險(xiǎn)分析，和工藝研發(fā)部協(xié)調(diào)中控事宜等）。
3. Execute processes according to batch strategy. Comply with SOP, HSE, and other guidelines
在合乎SOP（標(biāo)準(zhǔn)操作規(guī)程），HSE（安全環(huán)保健康）等規(guī)程的條件下，根據(jù)工藝操作規(guī)程執(zhí)行工藝。
4. Interact with R&D project teams and influence process development in order to guarantee feasibility and reliability of scale-up/commercial production.
能和工藝研發(fā)部項(xiàng)目組積極溝通反饋，支持工藝研發(fā)過(guò)程，以保證工藝放大/商業(yè)化生產(chǎn)的可行性和可靠性。
5. Consistently lead, advice, and guide manufacturing team in the day to day process operations assigned for assigned processes.
一如既往地指導(dǎo)和帶領(lǐng)相應(yīng)的操作團(tuán)隊(duì)執(zhí)行相關(guān)工藝的日常生產(chǎn)工作。
6. Fully responsible for complex equipment and systems independently
能獨(dú)立負(fù)責(zé)較為復(fù)雜的工藝設(shè)備和系統(tǒng)。
7. Ensure training to manufacturing team on assigned processes
確保生產(chǎn)團(tuán)隊(duì)得到相關(guān)工藝的培訓(xùn)。
8. Equipment and process troubleshooting
設(shè)備和工藝中出現(xiàn)問(wèn)題的解決。
9. Provide process improvement suggestions，Interpret process observations in order to identify potential improvements for ongoing process development
提供優(yōu)化工藝的建議，在整個(gè)生產(chǎn)過(guò)程中時(shí)時(shí)觀察/理解工藝現(xiàn)象，以便更好為可能的工藝改進(jìn)提供建議。
10. Ensure waste management in accordance with internal & external regulations (Exhaust air, effluent, liquid & solid waste)
在合乎內(nèi)部和外部的管理規(guī)定的前提下確保廢棄物管理流程的執(zhí)行（廢氣，廢液和廢固）。
11. Ensure reassembling & cleaning of equipment trains after manufacturing
在生產(chǎn)活動(dòng)結(jié)束后確保設(shè)備鏈復(fù)位及清洗。
12. Ensures proper and comprehensive batch record. Guide manufacturing team accordingly
確保生產(chǎn)批記錄填寫的完整性和正確性，對(duì)生產(chǎn)團(tuán)隊(duì)提供相應(yīng)的指導(dǎo)。
13. Perform internal Batch Record Review incl. deviation/change assessment for QA approval .Complete campaign report in a timely manner.
審閱生產(chǎn)批記錄（包括偏差/變更評(píng)估部分）。生產(chǎn)結(jié)束后及時(shí)完成生產(chǎn)總結(jié)報(bào)告。
14. Contribute to continuous plant optimization and process improvements initiatives對(duì)車間設(shè)備及工藝的持續(xù)優(yōu)化有所貢獻(xiàn)
15. Actively contributes to keeping the plant properly maintained and clean
積極參與車間維護(hù)和保潔。
16. Interacts with various support functions (e.g. warehouse & logistic, manufacturing officer) in order to guarantee smooth batch execution
積極和不同職能進(jìn)行溝通（如，倉(cāng)儲(chǔ)物流，生產(chǎn)主管等）以確保批次生產(chǎn)的順利進(jìn)行。
17. Regularly update Planning & Scheduling on the progress on the assigned tasks to facilitate resource allocation plans.
定期溝通項(xiàng)目生產(chǎn)最新進(jìn)展以便及時(shí)制定最新車間生產(chǎn)資源分配計(jì)劃。
18. Acts as point of contact for emergency response teams as appropriate.
根據(jù)需要，作為緊急響應(yīng)團(tuán)隊(duì)的聯(lián)系人。
19. Check all the infrastructure related facilities during operation as appropriate
根據(jù)需要，檢查車間公用工程系統(tǒng)以保證生產(chǎn)順利進(jìn)行。
20. Can take project specific the role as Expert Process
可根據(jù)工藝特殊需要擔(dān)任高級(jí)工藝專家的角色。
21. Various responsibilities in accordance to GMP HSE responsibility/deliverable
以及其它GMP,HSE相關(guān)的職責(zé)/交付。
Key Performance Indicators (Indicate how performance for this job is measured)
Quality (GMP), quantity, and timelines for all assigned tasks/projects保質(zhì)保量完成分配的任務(wù)
Compliance with standards, in particular, ethics, health, safety, and environment (HSE).合規(guī)，特別是在職業(yè)道德，健康，安全環(huán)境保護(hù)方面的合規(guī)
No LTA (lost time accident), RFT (right first time), Rework/reprocess Rates, deviations, batch failure.無(wú)損失工時(shí)的事故，一次成功率，再加工/返工率，偏差,失敗批等
Ideal Background (State the required education and experience levels)
Education (minimum/desirable): Formal education in organic synthesis related
與有機(jī)合成相關(guān)的教育
Languages: English preferred 有英語(yǔ)基礎(chǔ)優(yōu)先
Experience/Professional requirement:
1. Apprenticeship， or years of practical experience in organic chemical / pharmaceutical industry or related experience in field of expertise有有機(jī)合成經(jīng)驗(yàn)
2. Adequate IT application know how to fulfill role (ie word excel, drawing tools...)熟練使用電腦
3. Good knowledge of HSE/GMP standards and processes preferred有HSE GMP 經(jīng)驗(yàn)優(yōu)先

工作地點(diǎn)

遼寧省大連普灣新區(qū)松木島化工園區(qū)

職位發(fā)布者

孫永玲/人事經(jīng)理

三日內(nèi)活躍
立即溝通
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富樂(lè)馬鴻凱（大連）醫(yī)藥有限公司是一家專門從事手性醫(yī)藥中間體及其它特種功能精細(xì)化學(xué)品的研究開(kāi)發(fā)、生產(chǎn)和銷售的高新技術(shù)企業(yè)。公司自成立以來(lái)，根據(jù)市場(chǎng)的需要和國(guó)外知名企業(yè)的委托，成功研制了多個(gè)國(guó)際醫(yī)藥化工領(lǐng)域的最新產(chǎn)品，并已實(shí)現(xiàn)規(guī)模生產(chǎn)。同時(shí)，貯備了一大批有市場(chǎng)發(fā)展前景的手性醫(yī)藥中間體產(chǎn)業(yè)化技術(shù)；在手性合成、催化加氫、還原、胺化、氯化、氧化等領(lǐng)域形成了自身的技術(shù)特色。
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