CSV Validation Specialist - Life Sciences

ORKA LIFESCIENCE PARTNERS PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

ORKA LIFESCIENCE PARTNERS PTE. LTD. is seeking a CSV Consultant to support validation activities for computerized systems in regulated Life Sciences environments in Singapore. You will ensure GxP compliance and oversee documentation across URS, FDS, Risk Assessments, and validation plans.

The role requires 2–4 years in CSV or related quality roles, with strong understanding of Part 11/Annex 11 and ISPE GAMP5, and the ability to lead projects with minimal supervision.

Qualifications

• Bachelor's degree in Life Sciences, Engineering or related field.
• 2–4 years experience in CSV, Automation, or related regulated roles.
• Familiar with CSV lifecycle management and automation systems validation.
• Led a project from planning through execution and reporting.
• Able to manage stakeholders and deliverables within timelines.
• Able to work independently with minimal supervision.
• Understand CSV regulatory requirements (21 CFR Part 11, Annex 11) and ISPE GAMP5.
• Experience in change, incident and problem management is preferred.

Responsibilities

• Deliver CSV consulting projects to support implementation of computerized systems in Life Sciences clients with GxP compliance.
• Deliver CSV consulting projects to support OS upgrade for laboratory and manufacturing equipment.
• Draft, review and maintain CSV documentation (URS, FDS, Risk Assessments, etc.).
• Provide expert consultation to ensure regulatory compliance.
• Support CS activities like backup/restore and access management.
• Manage stakeholders from IT, Quality, Engineering, Operations to plan validation activities.
• Collaborate with IT/OT, automation and quality teams to deliver validation projects on schedule.
• Draft, revise and review SOPs, forms and related documents.

Skills

CSV Consulting

Regulatory Compliance

GxP Knowledge

Validation Lifecycle

Stakeholder Management

Project Leadership

Documentation

GAMP5

Part 11

Education

Bachelor's degree in Life Sciences/Engineering

Job description

ORKA LIFESCIENCE PARTNERS PTE. LTD. is seeking a CSV Consultant to support validation activities for computerized systems in regulated Life Sciences environments in Singapore. You will ensure GxP compliance and oversee documentation across URS, FDS, Risk Assessments, and validation plans.

The role requires 2–4 years in CSV or related quality roles, with strong understanding of Part 11/Annex 11 and ISPE GAMP5, and the ability to lead projects with minimal supervision.