CSV Engineer / Senior CSV Engineer (Remote / Onsite ) Singapore

Advanced Manufacturing Tech Solutions; Singapore; Hybrid; SGD 60,000 - 120,000; Full time

Job summary

AMTSOL in Singapore seeks CSV Engineers at multiple levels to support validation activities in GMP environments. Roles include onsite Singapore positions and senior remote projects on a global scale.

You will execute CSV lifecycle activities, perform IQ/OQ/PQ, and author validation documentation while mentoring teams and ensuring compliance across QA, Engineering, and Operations.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related discipline.
• 2–3 years CSV/validation experience in pharma or life sciences.
• Exposure to GMP, FDA 21 CFR Part 11, and GAMP 5.
• Remote or onsite validation experience in MES/automation environments preferred.

Responsibilities

• Execute CSV lifecycle activities across MES, automation, lab, and equipment systems.
• Perform IQ/OQ/PQ and validation documentation.
• Author, review, and approve validation protocols, test scripts, and reports.
• Lead CSV/CQV strategy for senior roles and manage deviation/change control.
• Collaborate with QA, Engineering, and Operations to ensure GMP compliance.
• Mentor junior engineers and manage cross-functional validation teams.
• Utilize e-validation tools like Kneat for paperless workflows.
• Remote roles: manage deliverables and stakeholder communication independently.

Skills

CSV expertise

Regulatory compliance

Leadership capability

Cross-functional collaboration

Education

Bachelor's degree in Engineering/CS

Master's degree preferred

Tools

Kneat

Job description

AMTSOL

A leader in Life Science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.

Job Titles

• CSV Engineer (Onsite, Singapore - 2-3 Years Experience)
• Senior CSV Engineer (Remote - 6+ Years Experience)
• Lead/Senior CSV Engineer (Remote - 9+ Years Experience)

About The Roles

We are hiring CSV Engineers at multiple levels to support validation activities in GMP-regulated pharmaceutical environments. Opportunities are available for onsite engineers in Singapore and senior professionals working remotely on global projects.

Key Responsibilities

• Execute Computerized System Validation (CSV) lifecycle activities across MES, automation, lab, and equipment systems.
• Perform Equipment Qualification (IQ/OQ/PQ) and system validation documentation.
• Author, review, and approve validation protocols, test scripts, and compliance reports.
• Lead and manage CSV/CQV strategy for senior roles, including deviation/change control.
• Collaborate with QA, Engineering, and Operations teams to ensure GMP and regulatory compliance.
• Mentor junior engineers and manage cross-functional validation teams (senior/lead levels).
• Utilize e-validation tools (e.g., Kneat) for paperless validation workflows.
• Remote roles: Independently manage deliverables, deadlines, and stakeholder communication without direct onsite supervision.

Requirements

CSV Engineer (Singapore - 2-3 Years)

• Bachelor’s degree in Engineering, Computer Science, or related discipline.
• 2-3 years of CSV/validation experience in pharma or life sciences.
• Familiarity with GMP, FDA 21 CFR Part 11, and GAMP 5.
• Exposure to MES validation, automation systems, or lab systems preferred.

Senior CSV Engineer (Remote - 6+ Years)

• Bachelor’s/Master’s degree in Engineering, Computer Science, or related discipline.
• 6+ years CSV experience in pharma/life sciences.
• Strong knowledge of GMP, GAMP 5, and global compliance frameworks.
• Proven expertise in MES validation, automation validation, lab system validation, and equipment qualification.
• Ability to work remotely with minimal supervision.

Lead/Senior CSV Engineer (Remote - 9+ Years)

• Bachelor’s/Master’s degree in Engineering, Computer Science, or related discipline.
• 9+ years CSV experience with leadership responsibilities.
• Demonstrated success in managing validation teams and complex global projects.
• Excellent stakeholder management, documentation, and leadership skills.
• Strong self-management and accountability in remote settings.