CSV Engineer

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

We are seeking a CSV Engineer to support manufacturing operations within a leading biopharmaceutical facility. The successful candidate will work closely with cross-functional teams to support a major migration and equipment validation programme within a regulated pharmaceutical environment.

Key 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.

Preferred Experience

• Diploma or Degree in Biotechnology, Life Sciences, Biochemical Engineering, Chemical Engineering, or related discipline.
• Strong, demonstrable hands‑on experience with CSV deliverables and activities, including validation documentation, QC testing, IQ/OQ, qualification and issue resolution.
• Good understanding of GMP/GDP expectations and regulated documentation practices.
• Ability to manage work independently, prioritise tasks and communicate effectively with technical and quality stakeholders.
• Experience working in a Singapore pharmaceutical environment or another comparable Singapore-regulated setting is strongly preferred.

What’s In It for You?

• Exposure to the major Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

What's Next?

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation, or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.