Validation Engineer

Posté 21 avr. 2022

Shanghai, Shanghai - China

Demander un identifiant 245310

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Your role:

Brief role description:

 

  • Schedule ongoing routine preventive maintenance, calibration and/or non-routine repair work on Instrument and other installed systems;
  • Coordinate equipment calibration, IQ/OQ/PQ, PM and repair with external vendor and ensure documentation as per GMP/GLP/GDP requirement
  • Timely complete equipment or software documentation and maintain record in BMRAM
  • Generate monthly report for calibration/PM/ Validation from BMRAM to inform lab the incoming equipment activities.
  • Timely collect movable equipment for external calibration
  • Timely Update equipment label for calibration, validation and routine PM.
  • Complete IQ/OQ/PQ and validation summary report within timeline and high quality
  • Assist to complete URS/SRA/FAT/SAT
  • Meet GXP requirement during executing equipment activities
  • Maintain Service contract database to reflect current service status
  • Archive equipment document timely per SOP defined frequency
  • May perform other related duties as required and/or assigned
  • Participate in any capital projects
  • Establish and maintain a good working relationship with contractors and internal customers
  • Work with Procurement for equipment maintenance & calibration quotations
  • Raising PR/PO within SAP systems
  • Participate in internal and external audits
  • Drafting internal Standard Operating Procedures for relevant areas eg Facilities
  • Completion of Quality Management System items (eg. events and CAPAs using relevant methods such as RCA, Fishbone etc.)
  • Support EHS team eg near miss, monthly inspections
  • Comply with all safety procedures and requirements;
  • Provide monthly training related to Facilities to new hires

 

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post.

 

Who you are:

 

Education & Qualification:

Bachelor degree or above, major in biology, chemical industry, analysis, medicine, facility management or equivalent Engineering discipline.

 

Experience:

Minimum 3 years of experience with laboratory equipment validation experience or relevant experience

Familiar with software validation

Working knowledge of GMP environment will be a plus.

Experience using Computerized Maintenance Management System (CMMS) for managing assets.

Experience using TrackWise or equivalent Quality Management Systems.

 

 

Knowledge and Skills:

  • Excellent problem solving, customer service and planning skills.
  • Ability to work independently & perform troubleshooting.
  • Ability to perform multitasking.
  • Comprehensive knowledge of applicable codes and enforcement standards, including SOP’s, systems history and change control.
  • Adheres to applicable safety SOPs and follows applicable safe work practices
  • Communicate effectively both orally and writing.
  • Customer/Client focus.

 

 

HR: 89829

Functional Area: Research & Development


 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

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