CSV Engineer / Senior CSV Engineer Singapore

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Singapore; Hybrid; SGD 70,000 - 140,000; Full time

Job summary

AMTSOL is hiring CSV Engineers at multiple levels to support validation activities in GMP-regulated pharmaceutical environments. Roles include onsite Singapore and remote global projects, offering exposure across MES, automation, lab, and equipment systems.

Senior/Lead roles require 6+ or 9+ years CSV experience, strong GMP/GAMP knowledge, and ability to manage cross-functional teams and remote deliverables using Kneat or similar tools.

Qualifications

• Bachelor’s degree in Engineering or related discipline.
• 6+ years CSV experience in pharma/life sciences.
• Exposure to GMP, FDA 21 CFR Part 11, and GAMP 5.
• Ability to work remotely with minimal supervision.

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 including 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 (Kneat) for paperless validation workflows.

Skills

CSV validation

Regulatory compliance

Remote work

Mentoring

Stakeholder management

Education

Bachelor's degree in Engineering

Master's degree in Engineering

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.