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Validation Engineer (CQV, Temperature Mapping)
Validation Engineer (CQV, Temperature Mapping)ALWAYSHIRED PTE. LTD. • Singapore, Singapore, Singapore
Validation Engineer (CQV, Temperature Mapping)

Validation Engineer (CQV, Temperature Mapping)

ALWAYSHIRED PTE. LTD. • Singapore, Singapore, Singapore
7 days ago
Job description

Responsibilities

  • Prepare equipment qualification deliverables including URS, risk assessments, data integrity assessments, specifications, CQ / IOQ protocols, and RTMs.
  • Execute equipment qualification activities such as temperature mapping for controlled temperature units and IOQ for laboratory and process equipment.
  • Monitor and support equipment vendors during commissioning, qualification, calibration, and maintenance activities.
  • Author data integrity documentation, such as Data Integrity Assessments, EREST assessments, and audit trail reviews for computerized systems.
  • Perform document control activities, including change control and management of qualification documents.
  • Draft, revise, and review SOPs, forms, and operational or maintenance documentation in compliance with GxP requirements.

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or related discipline.
  • Minimum 2 years of relevant experience in pharmaceutical, medical device, or other regulated industries.
  • Fresh graduates with relevant internships may be considered for a Junior role.
  • Experience working with manufacturing or laboratory equipment in a GMP environment.
  • Understanding of computerized system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11).
  • Preferably experienced in temperature mapping for controlled temperature systems (e.g., incubators, fridges, freezers, autoclaves, warehouses).
  • Advantageous if familiar with lab and process equipment such as process tanks, FIT machines, ViCell, spectrophotometers, pH / conductivity meters, and osmometers.
  • Experience with VLMS platforms such as Kneat is a strong plus.
  • Interested candidates please apply online or send your latest CV to

    AlwaysHired Pte Ltd

    Reg No : R

    EA : 24C2293

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    Validation Engineer • Singapore, Singapore, Singapore

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