ENGINEER

Ag Builders; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Ag Builders in Singapore seeks a seasoned CSV validation professional to lead and review validation activities for computerized systems in pharmaceutical manufacturing. The role focuses on ensuring compliance with GxP, 21 CFR Part 11, Annex 11, and GAMP 5, while coordinating with IT, QA and Manufacturing teams.

The ideal candidate has 5–8 years of CSV experience in regulated industries, strong documentation skills, and the ability to work independently and in cross-functional teams to support

Qualifications

• Bachelor's degree in a relevant 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, protocols (IQ/OQ/PQ), and reports for computerized systems.
• Perform risk assessments and impact analysis for system validation.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Collaborate with IT, QA, and Manufacturing to support system qualification and validation.
• Manage change control and deviation investigations for validated systems.
• Support audits and inspections by regulatory authorities.
• Maintain validation documentation and ensure traceability through the lifecycle.

Skills

CSV validation experience

Regulatory awareness

Documentation skills

Cross-functional collaboration

Independent worker

Education

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

Tools

PLC SCADA validation tools

MES validation

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.