Engineer

AG BUILDERS PTE. LTD.; Singapore; On-site; SGD 120,000 - 160,000; Full time

Job summary

AG BUILDERS PTE. LTD. in Singapore seeks a CSV Validation Specialist to lead qualification activities for computerized systems in pharmaceutical manufacturing. You will develop and review IQ/OQ/PQ validation plans, write reports, and ensure traceability across the system lifecycle.

The role requires 5–8 years of CSV experience, deep knowledge of GxP, 21 CFR Part 11, Annex 11, and GAMP 5, and strong collaboration with IT, QA, and manufacturing teams to support audits and regulatory inspections.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Engineering, CS, or related field.
• 5–8 years of CSV experience in pharmaceutical manufacturing or regulated industries.
• Strong knowledge of GxP, 21 CFR Part 11, Annex 11, and GAMP 5.

Responsibilities

• Develop and review validation plans, IQ/OQ/PQ, and reports for computerized systems.
• Perform risk assessments and impact analysis related to system validation.
• Collaborate with IT, QA, and Manufacturing to support qualification activities.
• Manage change control and deviation investigations for validated systems.
• Support audits and inspections by regulatory authorities.

Skills

CSV validation

GxP compliance

Regulatory standards

Documentation

Cross-functional teamwork

Education

Bachelor's degree in related field

Tools

Validation software

PLC/SCADA validation

GAMP 5 guidance

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 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.

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.