QUALITY VALIDATION ENGINEER

4 days ago

Tuas, Singapore APBA TG Human Resource Pte Ltd Full time $80,000 - $120,000 per year

Overview

We are seeking a highly driven Senior / Quality Validation engineer to support validation activities across manufacturing systems, equipment, processes, and computerized systems. This role ensures full compliance with GMP, regulatory expectations, and internal quality standards.

The Engineer will play a key role in reviewing validation documentation, leading validation activities, managing change controls, and supporting investigations, ensuring validated status is consistently maintained across the site.

Key Responsibilities

Validation Governance & Documentation


• Draft, review, and update validation policies, SOPs, protocols, and reports.

• Ensure documentation aligns with cGMP and current regulatory guidelines.

• Approve qualification deliverables (IQ/OQ/PQ) before progression to next phase.

Change Control & Compliance


• Review and assess changes impacting equipment, systems, or processes.

• Approve change controls and ensure accurate validation impact assessments.

• Support audits by providing validation documentation and compliance evidence.

Investigations & CAPA Support


• Participate in investigations to determine root cause and evaluate validation impact.

• Recommend corrective and preventive actions related to validation compliance.

• Ensure investigation records are complete, accurate, and timely.

Project & Validation Coordination


• Act as Validation Coordinator for projects with quality or regulatory impact.

• Lead validation-related discussions and ensure milestones meet project timelines.

• Support commissioning, qualification, FAT/SAT, and validation lifecycle activities.

Ongoing Validation Maintenance


• Conduct periodic validation reviews to confirm continued compliance.

• Recommend and plan re-validation based on review outcomes.

• Review and approve Continued Process Verification (CPV) documentation.

Qualifications


• Bachelor's degree in Science, Engineering, or a related field.

• 1 to 5 years of relevant experience in the pharmaceutical or biotech industry.

• Strong knowledge of GMP, validation lifecycle, and Computer System Validation (CSV).

• Experience with validation documentation, change control, and investigations.

• Strong attention to detail, analytical thinking.

• Ability to collaborate across functions and manage multiple validation tasks effectively.

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