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SENIOR LABORATORY VALIDATION ENGINEER [WK2149-10]

Job title: SENIOR LABORATORY VALIDATION ENGINEER [WK2149-10]
Contract type: Permanent
Location: South - Johor Bahru
Specialisation:
Industry: Manufacturing
Salary: Depending on Experience
Start date: 10 Jul 2021
Job Reference: 46332
Contact details: Wai Kin Lee
Contact email: WaiKin.Lee@jac-recruitment.com
Contact-phone: +60 7 278 1122
Job published: 27 days ago

JOB RESPONSIBILITIES

  • To execute the commissioning and qualification of testing machines, analytical equipment, instrumentation, and the laboratory computerized system.
  • Involved in Laboratory Equipment as well as Spreadsheet Validation.
  • To conduct periodic re-evaluation of all validated system/equipment in QC laboratories and accordingly plan for remediation activities based on necessity.
  • To support capacity expansion related activities for new production introduction to site.
  • To be in charge of analytical method validation and analytical method transfer
  • To develop validation documents and qualification / validation protocols.

JOB REQUIREMENTS

  • Possesses at least Diploma / Bachelor’s Degree in Life Sciences, Biomedical Engineering, or equivalent.
  • Have proven experience in handling commissioning, qualification process and analytical method validation in laboratory setting (equipment & computerized system), preferably 5 years of experience or above.
  • Good knowledge in GAMP requirement as well as USP <1058>.
  • Strong project management, analytical and troubleshooting skills.
  • Familiar with compliances for qualification and validation process as well as documentation.