Pharma CSV Engineer — GMP Validation Lead

Advanced Manufacturing Tech Solutions; Singapore; On-site; SGD 90,000 - 150,000; Full time

Benefits offered by this job

Career progression opportunities

Global pharma exposure

Training on e-validation tools

Job summary

Advanced Manufacturing Tech Solutions in Singapore seeks an experienced CSV Engineer to lead computerized system validation within GMP-regulated environments. You will drive validation across manufacturing systems and collaborate with QA, IT, and operations to ensure global standards are met.

The role requires 5+ years in pharmaceutical manufacturing or life sciences, strong CSV knowledge, and hands-on change control, deviation, and document control experience.

Qualifications

• Bachelor's degree required in engineering or a related field.
• At least 5 years of experience in pharmaceutical manufacturing or life sciences projects.
• Solid knowledge of CSV principles and regulatory standards.

Responsibilities

• Lead CSV lifecycle activities for manufacturing systems.
• Author and review deviation reports, change controls and operating plans.
• Develop and maintain IQ/OQ/PQ validation protocols and test scripts.
• Support validation projects including MES, automation, and IT systems.
• Collaborate with QA, document control and operations to ensure GMP compliance.
• Utilize Kneat or similar digital validation tools for paperless workflows.
• Provide training and guidance to junior engineers and cross-functional teams.

Skills

CSV validation

GMP compliance

Regulatory standards

Documentation

Stakeholder management

Communication

Education

Bachelor's degree in Engineering, Computer Science, or related discipline

Tools

Kneat

Job description

Advanced Manufacturing Tech Solutions in Singapore seeks an experienced CSV Engineer to lead computerized system validation within GMP-regulated environments. You will drive validation across manufacturing systems and collaborate with QA, IT, and operations to ensure global standards are met.

The role requires 5+ years in pharmaceutical manufacturing or life sciences, strong CSV knowledge, and hands-on change control, deviation, and document control experience.