CQV Engineer – controlled chambers

1 day ago


Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time
Roles & Responsibilities

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 ( freezers, incubators, 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.
Tell employers what skills you have

GMP
validation protocols
Temperature Controlled
Biotechnology
Compliance
Qualification Testing
Equipment Qualification
Audits
monitoring of temperature
Regulatory Requirements
Life Sciences
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