Validation Engineer

2 weeks ago

West Region, Singapore f415df96-4dcd-47b7-b0c3-ee2d44299fe2 Full time $60,000 - $90,000 per year
Key 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: R1549345

EA: 24C2293

We regret to inform that only shortlisted candidates will be notified. Please note that your response to this advertisement will constitute informed consent to the collection, use, and/or disclosure of personal data by AlwaysHired, its affiliates and, where necessary, to relevant third parties, for purposes such as job application processing, career advisory, research, and other administrative purposes, in compliance with the relevant provisions of the Privacy Policy available

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