6 months contract Validation Engineer (Pharma)

Recruit Express Pte Ltd| Date Posted: 15-Feb-2020
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Contract, Temporary
Position Level:
Entry Level, Experienced
Qualification:
Diploma, Bachelor's / Honours

Job Description

Jobscope:

  • Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with internal procedures and industry standards.
  • The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
  • Experienced to creates, reviews and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
  • Can lead investigation revolving around discrepancies identified during qualification activities.
  • Experience in coordinate the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
  • Experience in leading daily validation meetings with cross functional in resolving validation issues.
  • Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
  • Experience in ASTM2500 of process equipment commissioning and qualification (Ultrafiltration units and chromatography column is preferred)
  • Regular progress report of project deliverables to supervisor/project lead
  • Any other duties as assigned by supervisor/designated person.

Requirements:

  • Min Diploma/Degree in Science or Engineering or any related courses
  • Proficient in technical write up of validation lifecycle documentation
  • Knowledge in validation aspect under GMP environment
  • Min 2 years of validation experience 
  • Able to start work immediately

Interested applicants please send your resume to [Click Here to Email Your Resume]

Huang Jingsheng Kevyn (R1333338)
RECRUIT EXPRESS PTE LTD (99C4599)

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Recruit Express Pte Ltd