Engineer

MPR INTERNATIONAL PTE LTD; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

MPR INTERNATIONAL PTE LTD is seeking a CSV Validation Engineer in Singapore to develop and review validation plans, IQ/OQ/PQ, and reports for computerized systems. The role requires evaluating risk and ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

You will collaborate with IT, QA, and Manufacturing, manage change controls, support audits, and maintain thorough documentation to ensure traceability across the system lifecycle.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
• 5-8 years of CSV experience in pharmaceutical manufacturing or 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

Documentation skills

Communication

Independent work

Cross-functional teamwork

Education

Bachelor's degree in Pharmacy/Life Sciences/Engineering/CS

Tools

PLC SCADA

MES

Validation software

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.