CSV Validation Engineer

No deviation Pte Ltd.; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A pharmaceutical solutions provider in Singapore is seeking a Validation Engineer to support the validation lifecycle of automation systems primarily DeltaV. The role requires strong technical expertise in DeltaV coding, along with experience in protocol development and client collaboration. Candidates should have at least 3 years of relevant experience in a regulated environment, and there are opportunities for professional development and transition into a client-side role after six months.

Benefits

Generous Leave Policy

Comprehensive Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Qualifications

• Minimum 3 years of relevant CSV experience in a regulated (preferably pharmaceutical) environment.
• Hands-on commissioning experience with DeltaV, WinCC, Siemens, and Rockwell systems.
• Solid knowledge of cGMP, GAMP, and 21 CFR Part 11.

Responsibilities

• Develop, review, and update validation documentation including URS, protocol reports.
• Generate and review CSV protocols specifically for DeltaV processes.
• Support protocol execution by assisting test performers.

Skills

DeltaV coding and configuration

Automation testing

Excellent written and verbal communication skills

Project management

Problem-solving

Education

Degree in Engineering or Science

Tools

DeltaV

WinCC

Siemens

Rockwell

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 0s why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

This position supports the validation lifecycle of automation systems primarily DeltaV and other major DCS/SCADA/PLC platforms within a regulated pharmaceutical manufacturing environment. The role involves creating, reviewing, and maintaining CSV documentation such as URS, design reviews, risk assessments, and qualification protocols (SAT, IQ, OQ), as well as assisting in the execution and troubleshooting of validation activities. The candidate must possess strong technical expertise in DeltaV coding and configuration to ensure accurate protocol development and review. The role requires close collaboration with clients, vendors, and test performers, adherence to cGMP and GAMP guidelines, and active participation in meeting project milestones. Depending on performance, there is an opportunity to convert to a client-side position after six months.

Key Responsibilities

• Develop, review, and update validation documentation including URS, DR, criticality assessments, SAT/IQ/OQ protocols, reports, and exception reports.
• Generate and review CSV protocols specifically for DeltaV processes, ensuring alignment with regulatory and client requirements.
• Review vendor documentation and ensure completeness and compliance.
• Support protocol execution by assisting test performers and troubleshooting identified issues.
• Review executed protocols and reports in accordance with GMP and document quality standards.
• Monitor project progress and contribute to regular status reporting.
• Identify issues, escalate appropriately, and communicate effectively with client counterparts.
• Operate within defined project schedules and resource constraints to meet milestones.
• Support automation commissioning activities involving DeltaV, WinCC, Siemens, and Rockwell systems.
• Ensure adherence to safety standards and promote safe work practices at all times.

Required Qualifications

• Degree in Engineering or Science disciplines.
• Minimum 3 years of relevant CSV experience in a regulated (preferably pharmaceutical) environment.
• Strong understanding of DeltaV coding, configuration, and process design.
• Hands-on commissioning experience with DeltaV, WinCC, Siemens, and Rockwell automation systems.
• Experience in DCS operations, automation testing, and protocol development.
• Solid knowledge of cGMP, GAMP, GDP, 21 CFR Part 11, ICH Q10, and ASTM E2500 risk-based approaches.
• Ability to manage schedules, resources, and deliverables effectively.
• Proactive, self-driven, and capable of independent or team-based work.
• Excellent written and verbal communication skills.
• IT-literate with strong proficiency in Microsoft Office applications.
• Ability to work flexible hours or shifts according to project phases.
• Proven track record of adhering to and promoting safety requirements.

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.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you\'re passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.