Senior QC Validation Engineer – GMP CSV for Lab Systems

Coalesce Management Consulting; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Annual leave

Full health coverage

Training & development allowance

Job summary

Coalesce Management Consulting is seeking a QC Engineer on site in Singapore to support validation and lifecycle management of computerized systems and analytical lab equipment in GMP-regulated pharma/biotech environments.

You will lead CSV activities, develop validation documentation, review vendor qualifications, and coordinate testing with internal teams and external vendors to ensure compliant, high-quality outcomes.

Qualifications

• Bachelor's degree in life science (bi biology/biotech/biochemistry) required.
• Min. 5 years of deviation investigations experience in GMP pharma/biotech/manufacturing.
• Strong English communication, written and verbal; able to multitask in a fast-paced environment.

Responsibilities

• Lead and execute CSV activities for analytical laboratory computerized systems and related software.
• Develop, review, and execute validation documentation.
• Support qualification and validation of laboratory instruments and systems (HPLC, UPLC, GC-MS, UV-Vis, etc.).
• Perform impact assessments and validation activities for system upgrades and software migrations.
• Ensure compliance with ALCOA+, Data Integrity, GAMP 5, 21 CFR Part 11, Annex 11, and company quality standards.
• Review and approve vendor qualification documentation where applicable.
• Support deviations, investigations, CAPAs, and change controls for laboratory systems.
• Participate in FAT, SAT, system implementation, and commissioning activities.
• Coordinate with QC users and vendors to define testing requirements.

Skills

CSV

Communication

Multitask

Teamwork

Education

Bachelor's degree in Life Science

Tools

HPLC

UPLC

Job description

Coalesce Management Consulting is seeking a QC Engineer on site in Singapore to support validation and lifecycle management of computerized systems and analytical lab equipment in GMP-regulated pharma/biotech environments.

You will lead CSV activities, develop validation documentation, review vendor qualifications, and coordinate testing with internal teams and external vendors to ensure compliant, high-quality outcomes.