CSV Engineer - EPKS & TPS Validation Specialist

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

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.