CSV Specialist

No deviation Pte Ltd.; Singapore; On-site; SGD 90,000 - 140,000; Full time

Benefits offered by this job

Generous Leave Policy

Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Shape the Future

Job summary

No deviation Pte Ltd. in Singapore is seeking an experienced CSV Specialist with strong isolator systems expertise to support validation activities within a regulated life sciences environment.

You will lead CSV efforts for isolator systems, develop and review validation deliverables (VMPs, URS, FS/DS, IQ/OQ/PQ, TRACE matrices), and ensure risk-based validation from design through decommissioning, aligning with GxP and 21 CFR Part 11 requirements.

Qualifications

• 3–8 years of CSV experience in pharma/biotech environments.
• Strong hands-on isolator systems validation knowledge.
• Experience with paper-based validation environments.
• Good understanding of data integrity principles (ALCOA+).
• Familiar with GAMP 5 and validation lifecycle methodologies.
• Strong documentation and stakeholder communication skills.

Responsibilities

• Lead and execute CSV activities for isolator systems and related software.
• Develop and review validation deliverables: VMPs, URS, FS/DS, IQ/OQ/PQ, TMs.
• Support system lifecycle validation from design to decommissioning.
• Apply risk-based validation in line with industry standards.
• Manage paper-based validation documentation and approvals.
• Collaborate with Engineering, Automation, QA, and Vendors to align scope.
• Review vendor documentation for compliance and adequacy.
• Support deviations, CAPA, and change control for validated systems.
• Ensure compliance with GxP, 21 CFR Part 11, Annex 11.

Skills

CSV expertise

Isolator systems

Regulatory compliance

Documentation

GxP knowledge

Risk-based validation

Education

Bachelor's degree in Engineering

Tools

PLC

SCADA

HMI

Document Control

Job description

About No deviation

At No deviation, we are dedicated to delivering patient‑centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

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

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.