Computer System Validation Engineer (Senior)

INTEGRIX SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 90,000 - 120,000; Full time

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

Job Description:

• Create, review or approve validation deliverables for GMP computerized systems including but not limited to:
  • User Requirements Specifications
  • Design Reviews
  • Criticality assessments
  • Validation protocols (IQ, OQ, PQ)
  • Incident/deviation reports related to test protocol execution
• Provide validation guidance to cross-functional teams based on customers' Standard Operating Procedures (SOPs)
• Provide QA oversight and review during different phases of the automation & ITOT projects in the pharmaceutical manufacturing industry
• Validation of Process Control Systems and PLC system

Requirements:

• Degree in Engineering or Science, preferably in Chemical/Biochemical Engineering, Electrical Engineering or Computer Science/IT.
• Minimum 3 years of computer system validation or automation experience in Pharmaceutical manufacturing Industry
• Customer-focused and uphold high work quality standards
• Excellent communication skills - ability to communicate and collaborate effectively with various stakeholders
• Previous Emerson DeltaV, ITOT infrastructure, PLC experience is preferred
• Experienced in developing and reviewing automation validation deliverables
• Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10 guidelines