CSV Engineer

About the Role:
We are hiring a CSV Engineer to support pharmaceutical manufacturing projects in Singapore. The role focuses on validating GxP computerised systems to ensure compliance with relevant regulatory and data integrity standards across the project lifecycle.

Key Responsibilities:

• Author and review validation documentation (URS, FS, RTM, IQ/OQ/PQ protocols and reports).
• Perform risk assessments and impact analyses in alignment with GAMP 5 principles.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and applicable data integrity standards.
• Coordinate validation activities for QC, manufacturing, and automation systems.
• Liaise with internal departments (QA, IT, Engineering, Manufacturing) and vendors.
• Support audits and inspections by providing validation documentation and responses.
• Contribute to change control processes and periodic system reviews.

Requirements:

• Degree in Engineering, Computer Science, Life Sciences, or related field.
• Minimum 3–5 years of hands-on CSV experience in GMP-regulated environments (biologics/pharma).
• Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Experience validating systems such as LIMS, MES, PLC/SCADA, and lab equipment software is a plus.
• Excellent documentation and stakeholder coordination skills.