CQV Engineer

1 day ago

Singapore Unison Group Full time $90,000 - $120,000 per year

Role Overview

We are seeking a CQV Engineer with specialized experience in temperature mapping of controlled temperature chambers in GMP/GDP environments. The role requires strong knowledge of GDP principles, ALCOA data integrity standards, and experience authoring protocols and reports in Kneat.

Key Responsibilities

· Plan and execute temperature mapping studies for a variety of controlled chambers (refrigerators, freezers, incubators, warehouses, etc.).

· Draft and execute validation protocols, reports, and data integrity assessments.

· Perform equipment qualification activities (IQ/OQ/PQ) in compliance with GDP and ALCOA principles.

· Develop and review SOPs, deviation reports, and CAPAs related to temperature mapping.

· Support audits and inspections by providing validation evidence.

Collaborate with QA, Engineering, and Operations to ensure compliant practices

· Bachelor's degree in Engineering, Life Sciences, or related field.

· Experience in temperature mapping and qualification activities.

· Strong knowledge of GDP and ALCOA principles.

· Experience drafting protocols and reports in Kneat preferred.

· Familiarity with a wide range of temperature-controlled chambers advantageous.

Strong documentation skills

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