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Manufacturing Operator I – GeneChip Production

Thermo Fisher Scientific · Singapour

Junior 🇬🇧 English
ISO 13485:2003 21 CFR Part 820

Job description

About the role

As a Manufacturing Operator I you will set up and run equipment used to produce GeneChip® probe arrays in a cleanroom environment. You will ensure high‑quality output while adhering to strict GMP, ISO 13485 and 21 CFR 820 standards.

Key responsibilities

  • Follow ISO 13485:2003 and 21 CFR Part 820 requirements and report any non‑compliance immediately.
  • Perform routine, repetitive tasks within defined parameters and operate production equipment safely.
  • Maintain cleanroom housekeeping standards, including proper gowning and PPE usage.
  • Handle, store, and dispose of chemicals according to SOPs and safety guidelines.
  • Report spills, leaks, or exposure incidents and ensure prompt corrective actions.
  • Develop good working habits, notify Technical Specialists of tool or product issues, and alert Manufacturing Engineers to excessive downtime or defects.
  • Observe all safety procedures, keep the workspace organized, and report unsafe acts or conditions.

Required profile

  • Minimum secondary education; NTC in an engineering‑related field.
  • 1–3 years of hands‑on production or processing experience.

Required skills

  • Operation of manufacturing equipment in a cleanroom setting.
  • Knowledge of ISO 13485:2003 quality standards.
  • Familiarity with 21 CFR Part 820 medical device regulations.
  • Cleanroom protocols and proper use of PPE.
  • Safe handling, storage, and disposal of chemicals.

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Published 3 months ago

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Thermo Fisher Scientific

Singapour