Computer System Validation Engineer (Senior)

Integrix Solutions Pte Ltd; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

Integrix Solutions Pte Ltd in Singapore is seeking a Validation Specialist to create, review and approve validation deliverables for GMP computerized systems in pharmaceutical manufacturing. You will coordinate with cross-functional teams to ensure compliance with SOPs and regulatory requirements.

Responsibilities include validating Process Control Systems and PLCs, providing guidance on IQ/OQ/PQ and maintaining data integrity under cGMP, GDP, and 21CFR Part 11.

Qualifications

• Minimum 3 years of computer system validation or automation experience in pharma manufacturing.
• Ability to communicate and collaborate with stakeholders.
• Knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10 guidelines.

Responsibilities

• Create, review or approve validation deliverables (IQ/OQ/PQ).
• Provide validation guidance to cross-functional teams.
• QA oversight during automation ITOT projects in pharmaceutical manufacturing.
• Validate Process Control Systems and PLCs.

Skills

Validation experience

Cross-functional collaboration

Effective communication

Attention to quality

GxP knowledge

Education

Engineering or Science degree

Tools

Emerson DeltaV

ITOT infrastructure

PLC

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