Csv Engineer

5 days ago

Singapore COMBUILDER PTE LTD Full time

**Responsibilities**:

- Lead and execute Computerized Systems Validation (CSV) activities, including planning, testing, documentation, and reporting.
- 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.

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