Csv Engineer

5 days ago


Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

We are seeking an experienced **CSV Engineer**to support validation of computerized systems in a GMP-regulated pharma environment. The role involves developing and executing validation deliverables, ensuring compliance with **21 CFR Part 11, Annex 11, GAMP 5**, and collaborating with cross-functional teams for successful project delivery.

**Key Responsibilities**:

- Develop and execute validation plans, test plans, and qualification protocols ( **IQ, OQ, PQ, PPQ**) for lab, manufacturing, and automation systems.
- Perform **CSV deliverables**including URS, risk assessments, traceability, and test scripts.
- Ensure compliance with **data integrity (ALCOA+), 21 CFR Part 11, and GMP guidelines**.
- Manage **change control, deviations, CAPA, and risk assessments (pFMEA/dFMEA)**.
- Coordinate with QA, QC, IT, and Engineering for validation activities and project timelines.
- Maintain accurate documentation for audits and regulatory inspections.

**Qualifications & Skills**:

- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
- **3-6 years’ experience**in **CSV**within pharma/biotech/life sciences.
- Strong knowledge of **validation protocols (IQ/OQ/PQ/PPQ), data integrity, audit trails, and compliance standards**.
- Exposure to **Automation, DeltaV, PLCs, or MES systems**will be a strong advantage.
- Hands-on with **lab/analytical systems, LIMS, or automation control systems**preferred.
- Excellent problem-solving and documentation management skills.


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