Senior CQV Engineer - GMP Validation Expert

ENVIRODYNAMICS SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

EnviroDynamics Solutions Pte Ltd in Singapore seeks a validation specialist to lead full-lifecycle qualification of analytical instruments (HPLC/UPLC, GC, MS, UV-Vis, FTIR, PSA, dissolution, osmometers). You will draft protocols, URS/FS, risk assessments, and summary reports.

The role includes vendor qualification, deviation investigations, and ensuring cGMP compliance across bioprocess equipment and systems. Travel may be required.

Qualifications

• Experience in GMP validation disciplines and lifecycle approaches.
• Strong documentation and report-writing skills.
• Ability to work independently and in teams.

Responsibilities

• Execute full-lifecycle qualification (DQ/IQ/OQ/PQ) for analytical instruments.
• Draft validation protocols, risk assessments, URS/FS, and qualification summary reports.
• Manage vendor qualification activities and review third-party documentation.
• Develop validation plans and reports supporting system qualification and validation.
• Investigate deviations and prepare investigation and summary reports.
• Promote cGMP and regulatory compliance on projects.
• Travel readiness with international passport.

Skills

Validation

GMP

Quality Systems

Documentation

Communication

Project Work

Education

BE/B.Tech/Diploma in Biotechnology/Mechanical/Chemical Engineering

Tools

Documentum

Maximo

TrackWise

Job description

EnviroDynamics Solutions Pte Ltd in Singapore seeks a validation specialist to lead full-lifecycle qualification of analytical instruments (HPLC/UPLC, GC, MS, UV-Vis, FTIR, PSA, dissolution, osmometers). You will draft protocols, URS/FS, risk assessments, and summary reports.

The role includes vendor qualification, deviation investigations, and ensuring cGMP compliance across bioprocess equipment and systems. Travel may be required.