Lead Validation Engineer, GMP Pharma (Oral Liquids)

Hovid Bhd; Chemor; On-site; MYR 60,000 - 90,000; Full time

Job summary

Hovid Bhd in Malaysia seeks a Validation Engineer to plan, coordinate, and execute qualification activities for facilities, utilities, and manufacturing and packaging equipment supporting the oral liquid plant. You will ensure qualification readiness and lifecycle compliance in line with GMP and company quality standards.

You will develop and maintain CQVs: DQ, IQ, OQ, and PQ, lead HVAC, Purified water, and production area qualifications, review technical documents, manage deviations, CAPA, and

Qualifications

• Bachelor's Degree in Engineering, Pharmaceutical Science, or a related discipline.
• Experience in GMP pharmaceutical manufacturing.
• Working knowledge of qualification lifecycle principles (DQ, IQ, OQ, PQ).
• Understanding GMP, Annex 15, PIC/S guidance, risk-based qualification, and validation principles.
• Experience preparing or reviewing qualification protocols and reports, FAT/SAT records, deviations, CAPA, and change-control assessments.

Responsibilities

• Plan, coordinate, and execute qualification activities for facilities, utilities, and manufacturing and packaging equipment.
• Develop, execute, review, and maintain qualification protocols and reports (DQ/IQ/OQ/PQ).
• Lead qualification activities for equipment, production areas, and utilities.
• Review design/engineering documents and FAT/SAT records to confirm qualification readiness.
• Prepare and maintain validation documentation in compliance with GMP and document-control requirements.

Skills

Technical writing

Analytical skills

Problem solving

Project coordination

Documentation skills

Education

Bachelor's degree

Job description

Hovid Bhd in Malaysia seeks a Validation Engineer to plan, coordinate, and execute qualification activities for facilities, utilities, and manufacturing and packaging equipment supporting the oral liquid plant. You will ensure qualification readiness and lifecycle compliance in line with GMP and company quality standards.

You will develop and maintain CQVs: DQ, IQ, OQ, and PQ, lead HVAC, Purified water, and production area qualifications, review technical documents, manage deviations, CAPA, and