- Singapore
XOT SOLUTIONS PTE. LTD. Hiring! Full Time Computer System Validation (CSV) Engineer in , Earn up to SGD 9,000 - Ricebowl
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Job Description
Responsibilities
Role Overview
We are seeking a highly skilled
Computer System Validation (CSV) Engineer
to support our pharmaceutical operations in Singapore. In this role, you will be the subject matter expert responsible for ensuring that all GxP computerized systems remain in a validated state throughout their operational life. Your primary focus will be on Life Cycle Management (LCM) projects, including system upgrades, data migrations, continuous improvements, and system retirements.
You will work closely with Automation, Quality Assurance, IT, Engineering, and Manufacturing teams to ensure that all system modifications comply with internal procedures, local HSA regulations, and global regulatory standards (FDA 21 CFR Part 11, EU Annex 11, and GAMP 5).
Key Responsibilities
Life Cycle Management (LCM) Validation
Lead the end-to-end validation activities for existing GxP computerized systems undergoing upgrades, patches, or data migrations.
Develop, review, and execute validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, IQ/OQ protocols, Traceability Matrices, and Validation Summary Reports.
Execute and manage Periodic Reviews for critical computerized systems to ensure ongoing compliance.
Plan and execute system decommissioning and data archiving strategies in accordance with data integrity regulations.
Compliance & Risk Management
Conduct Quality Risk Assessments (QRA) and System Risk Assessments for LCM changes to determine the appropriate scope of validation testing.
Ensure all computerized systems comply with Data Integrity (ALCOA+) principles, GAMP 5 guidelines, 21 CFR Part 11, and EU Annex 11.
Cross-Functional Collaboration
Partner with System Owners, IT, and external vendors to evaluate the compliance impact of proposed system changes (Change Control management).
Provide guidance and training to operational teams on good documentation practices (GDP) and CSV standards.
Qualifications & Requirements
Education:
Bachelor’s Degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
Experience:
Minimum of 3–5 years of working experience in Computerized System Validation within the pharmaceutical, biotechnology, or medical device industry.
LCM Expertise:
Proven track record of handling post-implementation validation, system upgrades, and change controls for manufacturing or laboratory systems.
Regulatory Knowledge:
Deep understanding of GAMP 5 methodologies, FDA 21 CFR Part 11, EU Annex 11, PIC/S, and Data Integrity guidelines.
Technical Familiarity:
Experience validating enterprise or site-level systems such as MES (e.g., Syncade, Werum), DCS (e.g., DeltaV), LIMS, ERP (SAP), QMS, or chromatography data systems (e.g., Empower) will be a plus.
Skills:
Strong analytical and problem-solving abilities, excellent technical writing skills, and the capacity to manage multiple LCM projects simultaneously in a fast-paced environment.
Please drop an email to ************* if you are keen with the position and not able to apply through this web portal.
XOT Solutions is a regional leading provider of innovative solutions in the field of Operational Technology (OT). Our company specializes in designing, implementing, and supporting OT systems that enable our clients to optimize their operational performance, increase resiliency, and reduce downtime.
We offer a comprehensive range of services, including system integration, network design, cybersecurity, automation, and predictive maintenance. Our solutions are tailored to the specific needs of our clients, and we work closely with them to develop customized strategies that align with their business objectives.
At XOT Solutions, we are committed to delivering high-quality services and solutions that meet the highest standards of reliability, safety, and security. Our team of experts has extensive experience in the OT industry and is dedicated to staying up-to-date with the latest trends and technologies.
We are seeking a highly skilled
Computer System Validation (CSV) Engineer
to support our pharmaceutical operations in Singapore. In this role, you will be the subject matter expert responsible for ensuring that all GxP computerized systems remain in a validated state throughout their operational life. Your primary focus will be on Life Cycle Management (LCM) projects, including system upgrades, data migrations, continuous improvements, and system retirements.
You will work closely with Automation, Quality Assurance, IT, Engineering, and Manufacturing teams to ensure that all system modifications comply with internal procedures, local HSA regulations, and global regulatory standards (FDA 21 CFR Part 11, EU Annex 11, and GAMP 5).
Key Responsibilities
Life Cycle Management (LCM) Validation
Lead the end-to-end validation activities for existing GxP computerized systems undergoing upgrades, patches, or data migrations.
Develop, review, and execute validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, IQ/OQ protocols, Traceability Matrices, and Validation Summary Reports.
Execute and manage Periodic Reviews for critical computerized systems to ensure ongoing compliance.
Plan and execute system decommissioning and data archiving strategies in accordance with data integrity regulations.
Compliance & Risk Management
Conduct Quality Risk Assessments (QRA) and System Risk Assessments for LCM changes to determine the appropriate scope of validation testing.
Ensure all computerized systems comply with Data Integrity (ALCOA+) principles, GAMP 5 guidelines, 21 CFR Part 11, and EU Annex 11.
Cross-Functional Collaboration
Partner with System Owners, IT, and external vendors to evaluate the compliance impact of proposed system changes (Change Control management).
Provide guidance and training to operational teams on good documentation practices (GDP) and CSV standards.
Qualifications & Requirements
Education:
Bachelor’s Degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
Experience:
Minimum of 3–5 years of working experience in Computerized System Validation within the pharmaceutical, biotechnology, or medical device industry.
LCM Expertise:
Proven track record of handling post-implementation validation, system upgrades, and change controls for manufacturing or laboratory systems.
Regulatory Knowledge:
Deep understanding of GAMP 5 methodologies, FDA 21 CFR Part 11, EU Annex 11, PIC/S, and Data Integrity guidelines.
Technical Familiarity:
Experience validating enterprise or site-level systems such as MES (e.g., Syncade, Werum), DCS (e.g., DeltaV), LIMS, ERP (SAP), QMS, or chromatography data systems (e.g., Empower) will be a plus.
Skills:
Strong analytical and problem-solving abilities, excellent technical writing skills, and the capacity to manage multiple LCM projects simultaneously in a fast-paced environment.
Please drop an email to ************* if you are keen with the position and not able to apply through this web portal.
XOT Solutions is a regional leading provider of innovative solutions in the field of Operational Technology (OT). Our company specializes in designing, implementing, and supporting OT systems that enable our clients to optimize their operational performance, increase resiliency, and reduce downtime.
We offer a comprehensive range of services, including system integration, network design, cybersecurity, automation, and predictive maintenance. Our solutions are tailored to the specific needs of our clients, and we work closely with them to develop customized strategies that align with their business objectives.
At XOT Solutions, we are committed to delivering high-quality services and solutions that meet the highest standards of reliability, safety, and security. Our team of experts has extensive experience in the OT industry and is dedicated to staying up-to-date with the latest trends and technologies.
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