Computer System Validation (CSV) Engineer

SANTECH ENGINEERING PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading engineering firm in Singapore is seeking an experienced professional to develop and review validation plans for computerized systems. The ideal candidate will have a bachelor’s degree in a relevant field, 5-8 years of experience in computerized system validation within regulated industries, and a strong understanding of GxP regulations. Responsibilities include performing risk assessments, ensuring compliance with regulatory guidelines, and collaborating with cross-functional teams to support system qualification and validation activities.

Qualifications

• 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
• Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
• Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.

Responsibilities

• Develop and review validation plans, protocols, and reports for computerized systems.
• Perform risk assessments and impact analysis related to system validation.
• Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.
• Manage change control and deviation investigations related to validated systems.
• Support audits and inspections by regulatory authorities.
• Maintain validation documentation and ensure traceability throughout the system lifecycle.

Skills

System validation

Documentation

Communication

Cross-functional teamwork

Education

Bachelor’s degree in relevant field

Job description

Key Responsibilities:

• Develop and review validation plans, protocols (IQ, OQ,PQ), and reports for computerized systems.
• Perform risk assessments and impact analysis related tosystem validation.
• Ensure compliance with regulatory guidelines such asFDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Collaborate with IT, Quality Assurance, andManufacturing teams to support system qualification and validationactivities.
• Manage change control and deviation investigationsrelated to validated systems.
• Support audits and inspections by regulatoryauthorities.
• Maintain validation documentation and ensuretraceability throughout the system lifecycle.

Qualifications:

• Bachelor’s degree in Pharmacy, Life Sciences,Engineering, Computer Science, or related field.
• 5-8 years of experience in CSV within pharmaceuticalmanufacturing or related regulated industries.
• Strong knowledge of GxP regulations, 21 CFR Part 11,Annex 11, and GAMP 5 guidelines.
• Experience with validation of PLC SCADA, MES, or otherpharma manufacturing Automation systems.
• Excellent documentation and communication skills.
• Ability to work independently and in cross-functionalteams.