CQV QC Lab Engineer: Temperature Mapping & GMP

NO DEVIATION PTE. LTD.

Singapore

On-site

SGD 70,000 - 100,000

Full time

5 days ago

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Job summary

NO DEVIATION PTE. LTD. is seeking a QC CQV Engineer to lead commissioning, qualification, and validation of QC laboratory equipment, with a focus on temperature‑controlled units. You will support change control, protocol development, and data integrity to ensure GMP compliance.

In this role, you will collaborate with QC, QA, Engineering, and vendors to execute qualification activities, document outcomes, and drive continuous improvement across the laboratory equipment lifecycle.

Qualifications

Degree or Diploma in Engineering, Life Sciences, Biotechnology, or related field.
Experience in CQV, equipment qualification, and temperature mapping in a GMP environment.
Strong understanding of qualification principles, validation lifecycle, and regulatory requirements.
Good documentation, analytical, and problem-solving skills.
Strong attention to detail and compliance mindset
Good communication and technical writing skills
Ability to work independently and in cross-functional teams
Practical understanding of laboratory operations

Responsibilities

Perform temperature mapping of refrigerators, freezers, and other temperature-controlled equipment according to GMP requirements.
Analyze mapping data and ensure equipment meets acceptance criteria for uniformity and stability.
Support qualification activities including IQ/OQ/PQ for QC laboratory instruments.
Document all qualification activities in compliance with internal procedures and regulatory standards.
Draft validation documents such as URS, Risk Assessments, IQ/OQ/PQ protocols, and summary reports.
Execute qualification protocols in the QC laboratory environment.
Ensure deviations are documented, investigated, and resolved appropriately.
Initiate and manage Change Controls related to equipment qualification, upgrades, repairs, or replacements.
Ensure activities align with GMP, ALCOA+, and regulatory expectations.
Support audits by presenting qualification and validation documentation.
Work with QC, QA, Engineering, and vendors to coordinate qualification and maintenance activities.
Provide technical support to the QC team on equipment performance and compliance.
Participate in continuous improvement initiatives for laboratory equipment lifecycle management