Calibration Engineer (职位编号：2113909)社

面议

市辖区本科及以上4年及以上

发布时间：2023-09-06

职位描述

关于生物制药合同生产业务
勃林格殷格翰致力于成为中国***国际性生物制药合同生产供应商，为其在中国及全球的客户提供全方位的服务。作为生物制药合同生产的领导者，勃林格殷格翰将创新型商业模式成功引入中国，进一步促进了中国生物制药产业的发展，增强了全球竞争力，推动了中国创新药物的临床研究和市场推广的进程，将中国生物技术产业带入新纪元。公司先进的生产平台、领先的国际管理系统和全球生物制药网络将合力支持中国的生物药品打入全球市场。


工作职责Job Responsibilities
-Maintain Calibration Program for BioChina. Evaluate calibration requirements for new and existing equipments / systems, based on cGMP, and National / international regulatory Pharmacopoeia requirements. Coordinate the calibration activities for GMP process critical equipment/system，and ensure good management of calibration laboratory and its calibration tools, in order to deliver high quality calibration services.
-Provide professional technical knowledge on calibration, to support operation and maintenance activities. Acting as calibration lead Engineer, create and implement local SOP's, test methods, and GxP processes, in conjunction with Global calibration management procedures and processes.
-Take ownership for Calibration related change controls, improvement initiatives, Deviations, Investigations, CAPA's etc, to ensure safe, compliant, cost effective, reliable and efficiently optimized Calibrations.
-Coordinate the internal/external teams to manage the calibration master plan. Manage external service team to ensure strict calibration execution according to schedule.
-Continuously improves necessary technical knowledge to ensure the above three main purposes to be continuously fulfilled.
-Make provisions for appropriate Calibration related training of all involved personnel. Act as SME for all Calibration technicians for BioChina.
-Daily coordination / integration of work scheduling activities alongside maintenance, validation and production activities; assign personnel to perform tasks, based on pre-aligned schedules. Manage daily coordination of internal/external service suppliers to effectively perform tasks in time, budget and -Quality. Supervise work activities and be accountable for results.
-Monitor/Coordinate the calibration life-cycle process, performing periodic reviews, analytical trending, performance assessments to ensure reliable, controlled and compliant manufacturing processes.
-Maintain calibration related systems and their information master data i.e. SAP GBS, BIgCal. Ensure systems remain continuously updated to a high -Quality standard, and reflect the operational status of the Equipments / Instruments in the manufacturing field.
-Responsible for the effective execution of Change Controls, Deviations, Investigation, CAPAs Etc. relating to Calibration hardware and process.
-Takes lead role in Customer & Regulatory audits, in topics relating to the calibration Management Program for BioChina, and takes ownership of any subsequent observations.
任职条件Qualifications
-Degree: Bachelor or above degree.
-Major: Bio Engineering, Biopharmaceuticals, Biology, Biochemistry or related field.
-Language skills & proficiency: Good English skills in read and write.
-Required experience:
-At least three years calibration experience .
-Experience in the biopharmaceutical environment
-Knowledge of occupational safety and GMP
-Experienced user of MS Office
-Strong planning and organizational skills
-Targeted and autonomous working style
-Good English skills, both written and spoken
-Routine working with local teams, and collaboration with global experts as required
-Self-confident, self-motivate and results orientated
-Social competence, customer orientation and a good team player

其他要求

招聘人数：1人
职能类别：其他运营推广职位

公司介绍

关于勃林格殷格翰
加入勃林格殷格翰，与我们一起携手并肩，共创未来。我们深信每一位员工的成长都将铸就公司的发展，每一位员工的努力也都将成就公司的美好明天。130余年来，研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一，持续致力于人用药品、动物保健和生物制药合同生产三大业务领域，力争为人类和动物带来更多健康。加入勃林格殷格翰，将是您实现“创新展现价值”的绝佳机会！在工作中，您将通过与内外部伙伴的通力合作，站在知识迭代的最前沿；科研过程中，您将不断探索新型科学发现，切实提高全人类的生活质量；与此同时，您也将助力公司成为未来行业当之无愧的领导者。

我们的业务正处在持续高速发展之中，是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰，共同携手向前，成为实现2025愿景的一份子。

作为业内的领导企业，热情、创新和**是驱动我们不懈前行的动力，我们为每一位努力热忱、恪尽职守的员工提供成长机会，实现其个人价值。作为连续八年通过“中国杰出雇主”认证的企业，我们通过提供高质量的职业发展规划、参与或领导国际项目的机会，为每一位员工的成功之路*实基础。
让我们彼此成就，引领未来！

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-责任心：即使情况不明朗，我们总是在自己的决策和行为中展现主人翁精神
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-内部企业家精神：我们与客户携手构筑创新理念，以应对瞬息万变的市场

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