CSV Engineer (EPKS & TPS)

GAM-X ENGINEERING SERVICES PTE. LTD.; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A leading engineering services firm in Singapore seeks an experienced specialist in Computerized Systems Validation. The role involves ensuring compliance with regulations and coordinating qualifications for various automated systems in a GxP environment. Candidates should have a degree in Engineering or Science and substantial experience in CSV and Quality Assurance, along with strong knowledge of regulatory requirements. This position offers a competitive salary and opportunities for professional development.

Qualifications

• Minimum of 10 years' experience in relevant industry.
• At least 8 years in CSV, Quality Assurance, CQV.
• In-depth knowledge of GxP, GDP, CQV approaches.

Responsibilities

• Provide expertise in performing Computerized Systems Validation.
• Coordinate with internal and external teams for project objectives.
• Prepare and approve SOPs and qualification-related documentation.

Skills

Computerized Systems Validation

Regulatory compliance

Quality Assurance

Collaboration with engineering teams

Education

Degree in Engineering or Science

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 SOPs and qualification-related documentation (protocols and reports).
• Ensure that the qualification strategy is sound and adheres 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 10 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.