CSV Engineer

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

Key Responsibilities:

• Deliver CSV consulting projects to support implementation of computerized systems (e.g., DeltaV, Siemens PCS7, Rockwell PLCs) in the Life Sciences clients with compliance of GxP and other relevant regulatory standards.
• Deliver CSV consulting projects to support OS upgrade (e.g., Windows 11 upgrade) for laboratory and manufacturing equipment.
• Draft, review and maintain CSV documentation such as URS, FDS, Risk Assessment, Audit Trail Assessments, ERES assessments, Data Security Assessment, Validation Plans, IOPQ Protocols, RTM and any other lifecycle management documents.
• Provide expert consultation to ensure compliance with current regulatory requirements (e.g., GAMP5, 21 CFR Part 11, Annex 11).
• Support system configuration and computerised system (CS) activities such as backup and restore, access management, etc.
• Manage stakeholders from cross-functional teams (IT, Quality, Engineering, Operations) to plan and implement validation activities.
• Collaborate with other stakeholders including IT/OT, automation and quality teams to deliver validation projects on schedule.
• Draft, revise and review SOPs, forms and related operational and maintenance documents.

Requirements:

• Hold Bachelor's degree in Life Sciences, Engineering or related field.
• Possess 2-4 years of experience in Computer System Validation (CSV), Automation, or related quality and compliance roles within a regulated environment (pharmaceutical, medical device, etc.)
• Familiar with CSV lifecycle management and automation systems validation.
• Had experience in leading a project from planning through execution and reporting.
• Able to manage stakeholders and deliverables within project timelines.
• Must be able to work independently and deliver results under minimal supervision.
• Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5).
• Preferably with experience in change, incident and problem management.

Why Join ORKA:

• Work that Matters:Support clients bringing innovative and life saving solutions to the population.
• Career Development:Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment:Work with similar professionals possessingIntelligence, Resourcefulness, Loyalty and Teamworkcharacteristics.
• Impactful Learning and Mentoring:Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.