Process Engineer

Basic qualifications:

Education (minimum/desirable)教育: Bachelor Degree (Biological/or technical profile)

Minimum Education:最低教育: Bachelor Degree

Desired Education: 有以下教育经验更佳: Master Degree (Biological/or technical profile)

Languages所需语言:

Spoken 口语 / Written书写 / Read阅读

English英语 良好 fluent 良好 fluent 良好 fluent

Chinese中文 优秀 excellent 优秀 excellent 优秀 excellent

Experience工作经验:

Minimum 最低要求 : +5 year's experience in high quality healthcare international regulated industrial environment and in best manufacturing practices GMP.

Preferred qualifications:

Desired 有以下经验更佳:

  • Experience in sterile manufacturing including formulation, filling, freezer etc.,
  • Experience in technical support technology, such as washing & sterilization, CIP/SIP system
  • Knowledge of GSK GQP and GQMP, Well understanding of cGMP
  • Aware any project risk and necessary mitigation plan
  • Good communication skill

Skills (e.g. IT)) 工作技能 (如IT技能等) :

  • Good knowledge of operating experience of pharmaceuticals plants.
  • Good knowledge of cross functional business processes
  • Management knowledge establishing strong working relationships with customers and in-depth understanding of their operations and process requirements
  • Computer literate, MS office, CAD, MS Project
  • Flexibility in terms of working hours and travel
  • Self-motivated approach to responsibility and ownership
  • Ability to maintain deliverables by communication
  • Capability to maximize team performance
  • Strong analytical skills to identify the real issues quickly and to prioritise appropriately

Details:

Job Purpose:

The employee is allocated to one or more projects as Process Engineer located in GSK Tian Yuan site. He/she shall be responsible for development engineering solution and URS of the process equipment /facilities for site GMP remediation project to ensure the project continuity according to GSK standards and other requirements form company.

Major Accountabilities:

Engineering Design

  • Manage all process technology aspects of GSK TY vaccine engineering, being responsible for process engineering technology. Acts as an engineering technical lead on process engineering, implements local and global expert-inputs in a timely fashion with high quality.
  • Possesses excellent process design knowledge, is responsible for process equipment readiness including related automation of the entire facility within given budget, time and quality aspects.
  • Develops reliable and flexible process equipment concepts, summary as key inputs for URS preparation.
  • Leads and coordinates process sub teams and the engineering partners on process topics
  • Coordinate with global discipline SME on technical issue clarification and follow up with accurate remediation solutions
  • Advise and review all relevant technical documents for the project and work for the successful completion of the project and co-ordinate with other specialists.
  • Maintain good record on change management for project planning phase
  • Maintain a comprehensive filing system to provide a current basis for all documents, decisions, disposition of directives and inquiries and information exchanged among the parties, including agreements and modifications.

Procurement

  • Participate into procurement activities from technical point of view to evaluate the best offers for project, including RfQ documents preparation, bidding evaluation and clarification, contract & PR/PO preparation.
  • Provide the PM with updated information regarding the status of procurement works, especially for the long lead items.

Execution

  • Coordinate the CD/BD Program within process discipline, checking and reporting the actual onsite execution progress
  • Dealing with all contractors in planning, project time control and quality control.
  • Review, track and supervise any changes during execution phase.
  • In addition, responsible for developing commissioning plan and managing commissioning.
  • At the end, monitor all the changes reflected in the Contractor's "As-Built" drawings, support PM on project handover process.

Qualification

  • Coordinate and supervise all FAT/SAT/DQ/IQ/OQ works with contractors, engineering team and validation team
  • Prepare all necessary documentations to complete the validation works

Miscellaneous

  • Attend technical meetings and advise the Project Manager on procedures and requirements.
  • Daily organisation of project running and technical filing.
  • Coordinate with internal consultancy to ensure compliance with Corporate requirements
  • Coordination of technical requirements between the PM Team, global engineering and Consultants
  • Coordination with GSK internal Departments especially Sourcing/legal/Engineering/QA& QC
  • Other tasks assigned by supervision managers related to Process discipline

Key Performance Indicators:

  • Ensure GSK engineering standard fully implemented during each project execution phases
  • Support project manager to control project budget spending within +/- 10 %
  • Support project manager to control project milestones delivery time according to schedule
  • CAPA closure 80% on rate or greater
  • HSE review for all projects and zero lost time for accident and recordable at <=X%

Job Dimensions:

Number of associates下属人数:NA

Financial responsibility财务职责:N/A

(Budget预算, Cost成本, Sales销售, etc.)N/A

Key business partner主要工作联络部门: 制造事业部(Production)、QA、QC、Val、环境安全健康(EHS)

Contact information:

You may apply for this position online by selecting the Apply now button.

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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


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