CSV Engineer (EPKS & TPS)

CUTE MARINE SERVICES PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

CUTE MARINE SERVICES PTE. LTD. seeks a CSV specialist to lead computerized systems validation for automation, MES, and GMP equipment within GxP frameworks.

You will develop validation strategies, generate and review protocols and reports, and coordinate with engineering, quality, and vendors to ensure compliant turnover and documentation. The role requires 3–4 years in CSV and CQV, with deep knowledge of GxP, 21 CFR Part 11, and validation lifecycles.

Qualifications

• 3–4 years of experience in CSV, Quality Assurance, CQV, and Turnover Activities
• Strong understanding of Regulatory compliance (GxP, 21 CFR Part 11)
• Experience with validation lifecycle documents (URS, DQ, IQ/OQ/PQ)
• Familiar with CSV, GAMP 5, GDP and cGMP practices

Responsibilities

• Provides expertise in performing Computerized Systems Validation.
• Qualifies Automation Systems (PCS 7, EMS, MES) and GMP equipment.
• Collaborates with Compliance Engineering on CQV activities.
• Coordinates with internal and external teams to achieve site objectives.
• Prepares, reviews, and approves SOPs and qualification documents.
• Ensures validation strategy adheres to regulatory requirements and company standards.
• Investigates deviations and writes deviation reports.
• Raises and follows up change control records.

Skills

CSV validation

CQV

GxP knowledge

Regulatory compliance understanding

Education

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 3 years to 4 years of' experience in relevant industry with at least 3 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