制藥工藝工程師
- 發(fā)布日期：2010-2-5
- 截止日期：不限
- 學(xué)歷：本科
- 招聘人數(shù)：3
- 工作地點(diǎn)：天津、上海
職位描述
工作地點(diǎn)：天津、上海 具有設(shè)計(jì)院醫(yī)藥或化工工藝設(shè)計(jì)者，熟悉生物制藥、化學(xué)藥、中成藥、原料藥生產(chǎn)工藝、設(shè)備選型 職位描述： - 設(shè)計(jì)及優(yōu)化生物制藥或藥廠與其他工藝相關(guān)的擴(kuò)展性/可變性工藝； - 針對(duì)生產(chǎn)工藝或擴(kuò)大生產(chǎn)規(guī)模，選擇工藝設(shè)備，確定關(guān)鍵工藝參數(shù)； - 設(shè)計(jì)、優(yōu)化和詳述新的工藝設(shè)備，并編制設(shè)備使用說明等文件； - 根據(jù)cGMP要求，確保工藝設(shè)備具備合格資質(zhì)； - 對(duì)供應(yīng)商設(shè)備的報(bào)價(jià)分析、比較和選擇，供應(yīng)商跟蹤； - 項(xiàng)目前期HSE評(píng)估，風(fēng)險(xiǎn)評(píng)估； - 工藝流程制定，工藝、儀器裝設(shè)系統(tǒng)圖； - 設(shè)計(jì)審核，撰寫FAT、SAT，對(duì)IQ和OQ方案和測(cè)試計(jì)劃給出建議； 其他： - 負(fù)責(zé)客戶、供應(yīng)商、QA及技術(shù)采購(gòu)之間的協(xié)調(diào)； - 確保測(cè)試項(xiàng)的計(jì)劃實(shí)施； - 財(cái)政情況跟蹤； - 項(xiàng)目的情況報(bào)告。 職位要求： - 至少5年技術(shù)背景工作經(jīng)驗(yàn)； - 具有在以下1個(gè)或多個(gè)領(lǐng)域經(jīng)驗(yàn)： n 制藥設(shè)備； n 布局/ Room Classifications 分級(jí)/ 流程； n 清洗和滅菌、灌裝技術(shù)； n 物料管理和物流； - 熟知GMP和cGMP 者優(yōu)先； - 良好計(jì)算機(jī)能力，可以熟練使用P&ID, AutoCAD軟件。 Job Descriptions： The employee’s responsibilities are： •Design and optimize scalable processes for biotech or pharmaceutical factory in close cooperation with other disciplines •Select process equipment and determine critical process parameters relevant for design of production process or scale-up •Design, optimize, and specify new process equipment; compile user requirement documents •Qualify process equipment according to cGMP The employee must undertake some of the basic activities in connection with project execution: Basic design: • Establishment of User Requirements Specifications (URS) • Requirements Classifications • Quality Activity Plan (QAP) • Analysis of supplier quotations for machinery & equipment, comparison & selection • Initial HSE evaluation • Risk Assessment • PFD, Process Flow Description • PID, Process & Instrumentation Diagram Detailed Design: • Tender materials and ordering of machinery & equipment • Establishment of project plan • Supplier follow-up • Design Review • Writing FAT, SAT and give input to IQ and OQ protocols and test plans • Execution of FAT, SAT, IQ and OQ Other activities: • Coordination between customers, suppliers, QA, technical purchasing • Secure planning of test items • Financial status & follow-up • Overview of the project Job Requirements： • Minimum 5 years’ technical experience • You have experience in one or more part below: - Pharmaceutical Manufacturing Equipment - Layout/Room Classifications/Flow - Wash & Sterilization, Filing technologies - Warehouse & Logistic • GMP & cGMP knowledge is preferable. • Good computer skill in P&ID, AutoCAD.
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