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SENIOR LABORATORY VALIDATION ENGINEER [WK2149-10]

Job title: SENIOR LABORATORY VALIDATION ENGINEER [WK2149-10]
Contract type: Permanent
Specialisation: Engineering & Manufacturing
Industry: Manufacturing
Salary: Depending on Experience
Reference: en-49326
Job Reference: 46332
Contact details: Wai Kin Lee
Contact email: WaiKin.Lee@jac-recruitment.com
Job published: July 10, 2021 02:02

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.