CSV Engineer

PSC Biotech; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A global biopharmaceutical company is seeking an experienced candidate to develop and review validation plans, perform risk assessments, and ensure compliance with regulatory guidelines in Singapore. The ideal candidate has a Bachelor’s degree in a relevant field and 5-8 years of experience in computer system validation within a regulated industry. Strong documentation and collaboration skills are essential. This role offers a dynamic working environment and the opportunity to contribute to compliance and validation activities.

Qualifications

• 5-8 years of experience in CSV within pharmaceutical manufacturing or regulated industries.
• Strong understanding of GxP regulations.
• Experience with PLC SCADA, MES, or pharma manufacturing Automation systems.

Responsibilities

• Develop and review validation plans and protocols.
• Perform risk assessments and impact analysis.
• Ensure compliance with regulatory guidelines.
• Collaborate with IT and Quality Assurance teams.
• Manage change control and deviation investigations.
• Support audits and inspections by regulatory authorities.
• Maintain validation documentation.

Skills

Validation plans development

Risk assessment

Regulatory compliance

Collaboration with cross-functional teams

Change control management

Documentation skills

Education

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

Job description

Boon Lay Way, Singapore | Posted on 09/18/2025

• 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.

Requirements

• 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.