CSV Engineer

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

Job Title: CSV Engineer – Pharmaceutical Manufacturing

Location: Singapore

Employment Type: Full‑time

About The Role

We are seeking experienced CSV Engineers to join our team in Singapore. The role involves leading computerized system validation activities in GMP‑regulated environments, ensuring compliance with global standards, and supporting digital transformation initiatives.

Key Responsibilities

• Execute Computerized System Validation (CSV) lifecycle activities for manufacturing systems.
• Author and review deviation reports, change control documentation, and operating plans.
• Develop and maintain validation protocols (IQ/OQ/PQ) and system test scripts.
• Support system validation projects including MES, automation, and IT systems.
• Collaborate with QA, document control, and operations teams to ensure compliance with GMP, FDA 21 CFR Part 11, and GAMP 5.
• Utilize Kneat or similar e‑validation tools for paperless validation workflows.
• Provide training and guidance to junior engineers and cross‑functional teams.

Requirements

• Bachelor's degree in Engineering, Computer Science, or related discipline.
• Minimum 5 years of experience in pharmaceutical manufacturing or life sciences projects.
• Strong knowledge of CSV principles, GMP compliance, and regulatory standards.
• Hands‑on experience with deviation management, change control, and document control.
• Familiarity with Kneat or other digital validation platforms is an advantage.
• Excellent communication, documentation, and stakeholder management skills.

Employment Details

• Availability: Immediate/ASAP.

Why Join Us

• Work with leading pharma clients on high‑impact validation projects.
• Exposure to cutting‑edge paperless validation tools and global compliance standards.
• Collaborative, growth‑oriented environment with career progression opportunities.