Validation Engineer

ANTER CONSULTING PTE. LTD.; Singapore; On-site; SGD 75,000 - 95,000; Full time

Job summary

A leading company is seeking a Senior Validation Engineer to support a brownfield pharmaceutical facility project. The role involves developing validation strategies and protocols, ensuring GMP compliance, and collaborating with cross-functional teams to maintain readiness of equipment and processes. The ideal candidate must have extensive experience in GMP environments, particularly with temperature mapping and validation of clean utilities.

Qualifications

• Minimum 7 years’ experience in validation within GMP pharmaceutical environments.
• Hands-on experience in temperature mapping and clean utilities validation.
• Strong understanding of C&Q lifecycle and regulatory requirements.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment.
• Lead and coordinate temperature mapping activities.
• Collaborate with cross-functional teams to resolve qualification issues.

Skills

Temperature Mapping

Validation of Clean Utilities

Communication Skills

Stakeholder Management

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Pharmaceutical Sciences

Tools

Kaye Validator

Veeva

Kneat

TrackWise

Job description

Role Overview:

We are seeking an experienced Senior Validation Engineer to support a brownfield pharmaceutical facility project, with a dual focus on validation strategy and execution as well as close collaboration with the Commissioning & Qualification (C&Q) team. The successful candidate will play a key role in ensuring GMP compliance and readiness of equipment, systems, and processes, while also leading and executing temperature mapping and other critical validation activities.

Key Responsibilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for process equipment, utilities, and support systems.
• Lead and coordinate temperature mapping of warehouses, cold rooms, fridges, freezers, and controlled-temperature units using data loggers or Kaye Validator systems.
• Support the C&Q team with commissioning readiness, review of FAT/SAT documentation, and walkdowns.
• Author and manage validation plans, summary reports, and risk assessments (FMEA, impact assessments).
• Ensure alignment between C&Q deliverables and validation requirements for seamless handover and GMP compliance.
• Collaborate with cross-functional teams including QA, Engineering, and Manufacturing to troubleshoot and resolve qualification issues.
• Participate in and support audits, inspections, and deviation investigations related to validation activities.
• Track and report validation progress, ensuring documentation is ALCOA+ compliant and audit-ready.

Requirements:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related field.
• Minimum 7 years’ experience in validation within GMP pharmaceutical environments, including brownfield or retrofit projects.
• Hands-on experience in temperature mapping, validation of clean utilities (HVAC, WFI, etc.), and production equipment.
• Strong understanding of C&Q lifecycle, regulatory requirements (FDA, EMA), and data integrity principles.
• Familiarity with validation systems such as Kaye Validator, Veeva, Kneat, or TrackWise is advantageous.
• Excellent communication, documentation, and stakeholder management skills.