CSV Engineer

PSC Biotech Corporation; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading biotechnology company in Singapore is seeking a Validation Specialist with experience in Computer System Validation (CSV) within pharmaceutical manufacturing. The role involves developing validation plans, ensuring regulatory compliance, and collaborating with cross-functional teams. Ideal candidates will have a Bachelor’s degree and 5-8 years of relevant experience, strong knowledge of GxP regulations, and excellent communication skills.

Qualifications

• 5-8 years of experience in Computer System Validation (CSV) in pharmaceutical or regulated industries.
• Strong knowledge of GxP regulations and FDA regulations.
• Ability to perform risk assessments and impact analysis for system validation.

Responsibilities

• Develop and review validation plans and protocols for computerized systems.
• Ensure compliance with regulatory guidelines.
• Collaborate with teams to support validation activities.

Skills

System validation

Risk assessment

Documentation skills

Cross-functional teamwork

Education

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

Tools

PLC SCADA

MES

Job description

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.