CSV Engineer: GMP Validation & QC Systems Lead

Coalesce Management Consulting; Singapore; On-site; SGD 60,000 - 90,000; Full time

Benefits offered by this job

Annual leave benefits

Full Health coverage and benefits

Training and Development allowance

Job summary

Coalesce Management Consulting seeks a CSV Engineer to support manufacturing operations in a regulated biopharmaceutical facility in Singapore. The role involves leading CSV activities for equipment and computerised systems, and preparing validation documentation to support a major migration and validation programme.

You will collaborate with cross-functional teams across quality, engineering, IT and operations to ensure GMP/GDP compliance, perform IQ/OQ qualification work, and manage changes

Qualifications

• GMP/GDP regulated documentation practices.
• Hands-on CSV deliverables and validation documentation experience.
• Ability to manage tasks independently and communicate with technical/quality stakeholders.

Responsibilities

• Lead and support CSV activities for equipment and computerised systems in a GMP-regulated environment.
• Prepare, review and execute validation documentation, including protocols, test scripts, reports and change-control records.
• Perform and support qualification activities such as IQ/OQ, testing, deviation investigation and issue resolution.
• Work across QC, manufacturing/production and utilities equipment.
• Coordinate with OEM vendors on system backups, installations, upgrades, troubleshooting and technical queries.
• Support risk assessments, impact assessments and remediation actions relating to system changes.
• Ensure all work aligns with applicable GMP, GDP and site quality requirements.
• Collaborate with engineering, automation, IT, quality and operational stakeholders throughout the project lifecycle.

Skills

CSV engineering

GxP

IQ/OQ

Validation documentation

GMP/GDP

Education

Biotech/Life Sciences degree

Tools

Validation protocols

QC testing

Job description

Coalesce Management Consulting seeks a CSV Engineer to support manufacturing operations in a regulated biopharmaceutical facility in Singapore. The role involves leading CSV activities for equipment and computerised systems, and preparing validation documentation to support a major migration and validation programme.

You will collaborate with cross-functional teams across quality, engineering, IT and operations to ensure GMP/GDP compliance, perform IQ/OQ qualification work, and manage changes