CSV Engineer

COMBUILDER PTE LTD; Singapore; On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled validation expert to lead Computerized Systems Validation activities in a GxP-regulated environment. This role involves collaborating with compliance teams, preparing essential documentation, and ensuring adherence to regulatory standards. The ideal candidate will have extensive experience in developing validation strategies and a strong understanding of regulatory compliance. Join a forward-thinking company where your expertise will contribute to maintaining high-quality standards and continuous improvement in processes. If you are passionate about validation and compliance, this is an exciting opportunity to make a significant impact.

Qualifications

• 8+ years of experience in Computerized Systems Validation in a GxP-regulated environment.
• Strong proficiency in developing validation strategies and documentation.

Responsibilities

• Lead and execute Computerized Systems Validation activities including planning and testing.
• Prepare, review, and approve qualification documentation in accordance with GAMP 5 and GDP.

Skills

Computerized Systems Validation (CSV)

GxP Regulations

GAMP 5

SAP

Six Sigma

Good Documentation Practices (GDP)

Regulatory Compliance

Education

Degree in Computer Science

Degree in Engineering

Degree in Science

Tools

Trackwise

Kneat

Job description

Responsibilities:

• Lead and execute Computerized Systems Validation (CSV) activities, including planning, testing, documentation, and reporting.
• Serve as the subject matter expert (SME) for qualification of GMP-related Computerized Systems such as PCS 7 , EMS , MES , and other automated systems.
• Collaborate closely with the Compliance Engineering team to support commissioning, qualification, and validation (CQV) activities.
• Prepare, review, and approve qualification documentation (URS, DQ, FAT, SAT, IOQ, Summary Reports) in accordance with GAMP 5 , GDP , and 21 CFR Part 11 .
• Ensure validation strategies are aligned with internal quality standards and regulatory guidelines.
• Investigate and document deviations, ensuring timely closure with root cause analysis and corrective/preventive actions (CAPA).
• Manage change control records and ensure appropriate validation impact assessments.
• Maintain up-to-date knowledge of evolving GxP and regulatory requirements to ensure continued compliance and process improvements.
• Train and mentor junior validation team members as needed.
• Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
• Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

Requirements:

• Degree in Computer Science, Engineering, Science or related studies.
• At least 8 years’ experience in Computerized Systems Validation (CSV) in a GxP-regulated environment . Must have strong track record in developing Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
• Must have in-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle and Good Documentation Practices (GDP)
• High level of understanding in Regulatory compliance. Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
• Certified or highly skilled in Six Sigma methodology.
• Strong proficiency in SAP and other enterprise systems.
• Familiarity with tools like Trackwise , Kneat , or similar validation/documentation platforms.
• Previous experience supporting both clinical and commercial manufacturing environments is a plus.
• (Preferred) Applicant with training or certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS.