重庆招聘工程总监（偏设备方向）

河马

要新建厂房，英语要流利，天天和一个英国佬打交道，资历浅点可以，但是要肯学，会学

联系方式：13564288425 redrock.wu@p-link.cn

JOB DESCRIPTION:

·        Review and approvethe Engineering quality plan for the facility and manufacturing equipment.

·        Review and approvefacility design and “to be built” and “as built” drawings (these must also beapproved by QA). Ensure electrical standards are defined and implemented. Performa facility DQ.  

·        Develop UserRequirement specifications for process equipment and key items of service plant.  Work with equipment suppliers to ensureprocess attributes are delivered. Organise Factory Acceptance Testing and on-site delivery inspection acceptance.

·        Work with theQuality Validation organisation to perform documented commissioning andvalidation of manufacturing equipment and facility services (DQ,IQ,OQ,PQ) tothe required standard to support the sale of product in the required market (toUS 21CFR requirements, including Part 11).

·        Review and approvecalibration and maintenance routines (based on equipment running time orfrequency of use) and work with the Quality organisation to ensure suppliers ofchange part and consumables (especially filters or product contact parts) areaudited and on an Approved Supplier list and purchase specifications exist.  Lubricants for critical process equipment andservices must be of a suitable food grade and approved.  Calibration of critical devices must defineresponsibilities for calibration, QA, production and engineering staff. Fulltraceability for all parameters (relating field instruments to nationalstandards). If contracted out QA must approve the method and review and approvedata before use.

·        Develop andimplement a system of work scheduling for maintenance and calibration but toinclude statutory inspection and non-schedules work.  Records of all work performed must be kept(and where necessary in the Production Equipment log).

·        Develop andimplement a documentation system so that information received from suppliers,manuals, in-house procedures, maintenance records and staff training recordsare held securely (fireproof) and readily accessible.

·        Develop andimplement a plant and parts inventory system (Best practice: integrated withQuality, EHS and Finance systems). Records should be kept of Engineering storesreceipt and issue (ideally against job number). GxP critical spares are identified in the system.

·        Review and Approvechanges made to the process, product and maintenance methods.

·        Contribute toQuality Risk Assessments

·        PerformEngineering Risk Assessments (to include EHS) and contingency planning.

·        OrganiseEngineering Audits to ensure and document that the required standards areachieved and maintained.  Anydeficiencies should be documented in a formal Corrective and PreventativeAction (CAPA) system.

·        Define roles and responsibilities with Production personnelso that critical operations are clear in written procedures and performed byappropriately skilled and trained personnel (e.g. environmental conditions,equipment change-overs etc.).  

·        Implement Safe Systems of Work and Permit to Work (inparticular for LV, HV electrical systems, Welding, Pressure systems, equipmentguarding etc.).

·        Sponsor multifunctional continuous improvement initiativesof the Process (Lifecycle Management concept) through the use of data rationaletools and techniques (such as Operational Excellence).  Integrate such initiatives into the QualityReview process.

·        All engineering procedures and practice must equally applyto contractors

           ·       Manageteam performance and encourage individual development.

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河马

Equipment & Facility

Recruit and lead the Engineering Team and have accountability for standards and team performance.  This team will comprise Engineering Technicians with multiple technical disciplines to specify, operate and maintain specialised manufacturing equipment in a dedicated facility.

To develop and direct a strategic Engineering plan to develop the facility and process equipment. Work with local design institutes and contractors to ensure a facility compliant with US standards is delivered.
Work with equipment consultants and international suppliers to develop company URS and purchase specifications.  Access requirements and approve FAT/SDI.  
Lead the Commissioning and validate the new facility along with the complex, specialised manufacturing equipment, for the development, registration and manufacture of inhalation products.
•        Initially dry powder inhaler (DPI) but may include line extensions (e.g. propellant Metered Dose Inhalers (pMDI)).
•        This will include formal definition of a User Requirement Specification, Functional Specifications, Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification (validation) of facilities, services and production equipment.

Ensure appropriate standards are applied to facility construction and maintenance (e.g. ISPE); in particular ensure the HVAC installation facilitates frequent environmental monitoring to US Class C in designated process areas; develop in house capability to perform these tests.  Purified water for equipment cleaning must meet USP requirements.  Dust extraction in process areas must facilitate drug product changes with no risk of cross-contamination.


Quality & EHS

Ensure the company Quality and EHS management systems are implemented in Engineering activities and staff are trained in Policies and procedures.  

Continuous Improvement

Sponsor multifunctional continuous improvement initiatives of the Process (Lifecycle Management concept) through the use of data rationale tools and techniques (such as Operational Excellence). This must apply to environmental monitoring and equipment performance trends. Integrate such initiatives into the Quality Review process.

resuper114

我比较感兴趣，就是太远了！

幻影

这个够挑战。

yuefen8173356

英语不怎么地，不过机会挺不错的，可以去学英语了

lp4502888

英语是硬伤啊{:soso_e109:}

河马

英语是大部分搞设备和工程的硬伤啊

qdxuanyu

英语我永远的。。。

河马

希望大家可以帮忙介绍合适的朋友！

laevo

河马 发表于 2014-9-25 09:10
希望大家可以帮忙介绍合适的朋友！

找到合适的了吗？可以到外资工程公司试试。。。

河马

laevo 发表于 2014-10-14 14:53
找到合适的了吗？可以到外资工程公司试试。。。

谢谢  已经在复试了 估计可以搞定