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.
