CSV Engineer (EPKS & TPS)

CUTE MARINE SERVICES PTE. LTD.

Islandwide, Singapore
Not specified
Computer system validation (csv)
Gamp 5 and 21 cfr part 11 compliance
Siemens pcs7 and plc systems
CUTE MARINE SERVICES PTE. LTD. is seeking a CSV Engineer to oversee Computerized Systems Validation, with a focus on qualification of automation systems and GMP equipment in compliance with GxP regulations. The ideal candidate should have a degree in Engineering or Science, with 3-4 years of experience in CSV activities and a strong understanding of regulatory compliance. ###

Job Summary

  • The role serves as the primary expert for qualifying computerized systems including Automation Systems and GMP equipment within a regulatory framework.
  • Candidates will coordinate with internal manufacturing, engineering, quality teams, and external vendors to ensure site objectives are met through robust validation strategies.
  • The position requires in-depth knowledge of the validation lifecycle from User Requirement Specifications through to IQ/OQ/PQ reports and risk assessments.

Matching Summary

Match Score: 85

CUTE MARINE SERVICES PTE. LTD. is seeking a CSV Engineer to oversee Computerized Systems Validation, with a focus on qualification of automation systems and GMP equipment in compliance with GxP regulations. The ideal candidate should have a degree in Engineering or Science, with 3-4 years of experience in CSV activities and a strong understanding of regulatory compliance. ###

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • GAMP 5 and 21 CFR Part 11 compliance
  • Siemens PCS7 and PLC systems
  • Validation lifecycle documentation
  • Deviation investigation and change control

Nice-to-have

  • Hardware and Fieldbus communication training
  • Batch process operations experience
  • EPKS & TPS specific knowledge
  • Collaborative work with external vendors
  • Flexibility to adapt to new regulations

Key Requirements

  • Degree in Engineering or Science
  • 3 to 4 years relevant industry experience
  • Minimum 3 years in CSV activities
  • In-depth knowledge of cGMP and GDP
  • Experience with Takeda domain systems preferred

Work Rights

Not specified

Tailored Resume

Cover Letter