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Posted on:
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Job Summary
Job Title: CSV Engineer Pharmaceutical Manufacturing
Location: Singapore Employment Type: Fulltime
About the Role
We are seeking experienced CSV Engineers to join our team in Singapore. The role involves leading computerized system validation activities in GMPregulated 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 evalidation tools for paperless validation workflows.
- Provide training and guidance to junior engineers and crossfunctional teams.
Requirements
- Bachelors 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.
- Handson 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 highimpact validation projects.
- Exposure to cuttingedge paperless validation tools and global compliance standards.
- Collaborative growthoriented environment with career progression opportunities.
