CSV Engineer (EPKS & TPS)

GAM-X ENGINEERING SERVICES PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

GAM-X Engineering Services PTE. LTD. seeks a seasoned CSV/CQV specialist to lead validation activities for automation and GMP systems in a regulated environment.

You will work with engineering, manufacturing, and quality teams to develop and execute validation plans, protocols, and reports, ensuring compliance with GxP, 21 CFR Part 11, and cGMP. The role emphasizes documentation rigor and change control management.

Qualifications

• Degree in Engineering/Science or related studies.
• Minimum of 4 years' experience in relevant industry with at least 8 years in CSV, Quality Assurance, CQV, and Turnover Activities
• High level of understanding in Regulatory compliance
• Familiar with Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, cGMP and GDP
• Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation)
• Works with Engineers to develop Validation Strategy, plans, protocols, reports, risk assessment, traceability matrices
• Develop Validation Master Plans (VMP), System Level Impact Assessments, and FAT/SAT/IQ/OQ/PQ
• Creation and/or review of validation lifecycle documents and reports
• Preferred training or Certification in Hardware and Fieldbus, Batch process Operations with EPKS & TPS

Responsibilities

• Provides expertise in performing Computerized Systems Validation.
• Primary personnel for qualification of CS including PCS 7, EMS, MES and GMP equipment qualifications.
• Collaborate with Compliance Engineering on CQV activities.
• Coordinate with internal and external teams to achieve site objectives.
• Prepare, review, and approve SOPs and qualification documents.
• Ensure qualification strategy adheres to standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

Skills

CSV

GxP compliance

21 CFR 11

GAMP 5

CQV

Validation lifecycle

Documentation

Education

Bachelor's degree in Engineering/Science

Tools

DCS

MES

MDW

BAS

PLC

Job description

Responsibilities

• Provides expertise in performing Computerized Systems Validation.
• Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
• Perform collaborative work with the Compliance Engineering team on other CQV activities.
• Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
• Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
• Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

Requirements

• Degree in Engineering/Science or related studies.
• Minimum of 4 years' experience in relevant industry with at least 8 years in CSV, Quality Assurance, CQV, and Turnover Activities
• High level of understanding in Regulatory compliance
• Primarily responsible for supporting all computer validation aspects to the automation and engineering teams. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
• Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
• In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
• Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
• Develop Validation Master Plans (VMP), System Level Impact Assessments, and executed FAT, SAT, and Validation Protocols (IQ, OQ, PQ).
• Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
• Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS