CSV Specialist

No deviation; Singapore; On-site; SGD 70,000 - 90,000; Full time

Benefits offered by this job

Generous Leave Policy

Comprehensive Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Shape the Future

Job summary

No deviation in Singapore is seeking an experienced Computer System Validation Specialist to support validation activities in a highly regulated life sciences environment. The successful candidate will lead CSV for isolator systems, ensuring compliance with regulatory standards and industry practices.

The role demands a bachelor's degree in a relevant discipline, 3-8 years of experience in CSV, hands-on knowledge of isolator systems, and the ability to manage documentation effectively.

Generous leave, health coverage, and professional development opportunities are offered.

Qualifications

• 3–8 years of experience in CSV within pharmaceutical/biotech environments.
• Experience working in a paper-based validation environment.
• Good understanding of validation lifecycle methodologies.

Responsibilities

• Lead and execute CSV activities for isolator systems.
• Develop and review validation deliverables such as Validation Plans and URS.
• Collaborate with cross-functional teams to ensure validation scope alignment.

Skills

Hands-on experience in isolator systems validation

Strong documentation and stakeholder communication skills

Familiarity with automation systems (PLC, SCADA, HMI)

Experience with data integrity principles (ALCOA+)

Education

Bachelor's degree in Engineering, Life Sciences, or related discipline

Tools

GAMP 5

Job description

Position Overview

We are seeking an experienced Computer System Validation (CSV) Specialist with strong expertise in isolator systems to support validation activities within a regulated life sciences environment. The successful candidate will play a key role in ensuring that automated systems associated with isolators are validated in compliance with regulatory expectations and industry best practices, using a paper‑based validation approach.

Key Responsibilities

• Lead and execute CSV activities for isolator systems and associated software platforms
• Develop and review validation deliverables, including:
  • Validation Plans / Validation Master Plans (VMP)
  • User Requirements Specifications (URS)
  • Functional / Design Specifications (FS/DS)
  • Risk Assessments (GAMP 5 aligned)
  • IQ/OQ/PQ protocols and reports
  • Traceability Matrices
• Support system lifecycle validation from design through to decommissioning
• Apply risk‑based validation approaches in line with industry standards
• Execute and manage paper‑based validation documentation and approvals
• Collaborate with cross‑functional teams (Engineering, Automation, QA, Vendors) to ensure alignment on validation scope and execution
• Review and assess vendor documentation for compliance and adequacy
• Support deviations, CAPA, and change control related to validated systems
• Ensure compliance with applicable regulatory standards (e.g., GxP, 21 CFR Part 11, Annex 11)

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline
• 3–8 years of experience in CSV within pharmaceutical / biotech environments
• Strong hands‑on experience in isolator systems validation
• Familiarity with automation systems (e.g., PLC, SCADA, HMI) linked to isolators
• Experience working in a paper‑based validation environment
• Good understanding of data integrity principles (ALCOA+)
• Experience with GAMP 5 and validation lifecycle methodologies
• Strong documentation and stakeholder communication skills

Benefits

• Generous Leave Policy
• Comprehensive Health & Wellness Coverage: robust medical and dental coverage
• Professional Development Opportunities: continuous learning programs and resources for career growth
• Inclusive Culture: innovation, collaboration, and diverse perspectives encouraged and celebrated
• Shape the Future: make a real difference in the pharmaceutical industry while advancing your career