Senior CSV Engineer - Pharma Automation & Validation

INTEGRIX SOLUTIONS PTE. LTD.

Singapore

On-site

SGD 90,000 - 120,000

Full time

11 days ago

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Job summary

INTEGRIX SOLUTIONS PTE. LTD. is seeking a validation engineer to support GMP computerized systems in our pharmaceutical manufacturing projects. You will create, review, and approve validation deliverables and provide cross-functional guidance across teams.

The role requires a degree in engineering or science and at least 3 years of validation experience, with familiarity in cGMP, GAMP, GDP, 21 CFR Part 11 and ICH Q10.

Qualifications

Degree in Engineering or Science required.
Minimum 3 years validation or automation experience in Pharmaceutical manufacturing.
Customer-focused with high quality standards.
Excellent communication and collaboration with stakeholders.
Emerson DeltaV, ITOT infra, PLC experience preferred.
Experience developing and reviewing automation validation deliverables.
Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10.

Responsibilities

Create, review or approve validation deliverables for GMP computerized systems (IQ/OQ/PQ).
Provide validation guidance to cross-functional teams per SOPs.
Provide QA oversight during automation & ITOT projects in pharma manufacturing.
Validate Process Control Systems and PLC systems.

Skills

Communication skills

Stakeholder collaboration

Customer-focused

Problem solving

Quality mindset

Education

Bachelor's degree in Engineering or Science

Preferred fields: Chemical/Biochemical Eng, Electrical Eng or CS/IT

Tools

Emerson DeltaV

ITOT infrastructure

PLC experience

Job description

The role requires a degree in engineering or science and at least 3 years of validation experience, with familiarity in cGMP, GAMP, GDP, 21 CFR Part 11 and ICH Q10.

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