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.
Qualifications & Requirements
Bachelor’s degree in Engineering, Life Sciences, or related field.
2–5 years of 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.
Top Skills
Unison Consulting Singapore Office
1 Changi Business Park Crescent, , Plaza 8 #03-06 Tower A, Singapore, , Singapore, 486025
Unison Consulting Singapore Office
#12-00, 63 Market Street, Bank of Singapore Center, Singapore, , Singapore, 048942
