ENGINEER

Lisen Builders Pte. Ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Lisen Builders Pte. Ltd. in Singapore seeks an experienced CSV validation professional to drive qualification and validation activities for pharmaceutical manufacturing systems.

You will develop and review validation plans and reports (IQ/OQ/PQ) and perform risk assessments, ensuring compliance with GxP guidelines, FDA 21 CFR Part 11, Annex 11, and GAMP 5. Collaboration with IT, QA, and production teams is essential to maintain traceability and support audits.

Qualifications

• Bachelor’s degree or higher in a 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.
• Experience validating PLC SCADA, MES, or similar 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 FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• 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 throughout the system lifecycle.

Skills

CSV validation

GxP compliance

Regulatory guidelines

Risk assessment

Documentation

Cross-functional teams

Education

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

Tools

PLC SCADA

MES

Automation systems

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.