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CSV Engineer Job Opening In Singapore, Singapore – Now Hiring ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD.


Job description

We are seeking an experienced CSV Engineer to support validation of computerized systems in a GMP-regulated pharma environment.

The role involves developing and executing validation deliverables, ensuring compliance with 21 CFR Part 11, Annex 11, GAMP 5 , and collaborating with cross-functional teams for successful project delivery.

Key Responsibilities

  • Develop and execute validation plans, test plans, and qualification protocols ( IQ, OQ, PQ, PPQ ) for lab, manufacturing, and automation systems.

  • Perform CSV deliverables including URS, risk assessments, traceability, and test scripts.

  • Ensure compliance with data integrity (ALCOA+), 21 CFR Part 11, and GMP guidelines .

  • Manage change control, deviations, CAPA, and risk assessments (pFMEA/dFMEA) .

  • Coordinate with QA, QC, IT, and Engineering for validation activities and project timelines.

  • Maintain accurate documentation for audits and regulatory inspections.

  • Apply GAMP 5, V-Model, and Agile methodologies in validation lifecycle.

Qualifications & Skills

  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.

  • 3–6 years' experience in CSV within pharma/biotech/life sciences.

  • Strong knowledge of validation protocols (IQ/OQ/PQ/PPQ), data integrity, audit trails, and compliance standards .

  • Exposure to Automation, DeltaV, PLCs, or MES systems will be a strong advantage.

  • Hands-on with lab/analytical systems, LIMS, or automation control systems preferred.

  • Excellent problem-solving and documentation management skills.

Required Skill Profession

Other General


  • Job Details

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Unlock Your CSV Engineer Potential: Insight & Career Growth Guide


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Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for CSV Engineer in Singapore, Singapore, highlighting market share and opportunities for professionals in CSV Engineer roles.

29920 Jobs in Singapore
29920
25484 Jobs in Singapore
25484
Download Csv Engineer Jobs Trends in Singapore and Singapore

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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. adheres to the cultural norms as outlined by Expertini.

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1. Independence

2. Loyalty

3. Impartiapty

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6. Respect for human rights

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