Senior CSV Engineer — Remote, Global Projects

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 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.