Computer System Validation (CSV) Engineer

SANTECH ENGINEERING PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Santech Engineering Pte. Ltd. seeks a senior CSV validation specialist to oversee validation plans and reports for computerized systems in pharma manufacturing.

You will lead risk assessments, ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5, and collaborate with IT, QA, and manufacturing to qualify systems. Ideal candidates have 5–8 years of CSV experience in regulated settings, strong documentation skills, and the ability to work independently within cross-functional teams.

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
• 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.
• Excellent documentation and communication skills.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Develop and review validation plans, protocols (IQ, OQ, PQ), 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

GxP knowledge

Documentation

Communication

Independent work

Cross-functional teamwork

Education

Bachelor's degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related 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.