Validation Engineer (pharma)

Hovid Bhd; Chemor; Sur place; MYR 60 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Technical writing

Analytical skills

Problem solving

Project coordination

Documentation skills

Formation

Bachelor's degree

Description du poste

The Validation Engineer plans, coordinates, and executes qualification activities for facilities, utilities, and manufacturing and packaging equipment supporting the oral liquid plant. The role ensures qualification readiness, lifecycle compliance, and continued validated status in accordance with GMP, regulatory requirements, and company quality standards.

Key responsibilities

Develop, execute, review, and maintain qualification protocols and reports covering Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.

Lead qualification activities for manufacturing and packaging equipment, production areas, facilities, and supporting utilities.

Plan qualification deliverables, schedules, supporting resources, and execution activities in line with project and operational requirements.

Lead qualification activities for HVAC systems, purified-water systems, compressed-air systems, production areas, and supporting utilities.

Review User Requirement Specifications, design and engineering documents, commissioning records, Factory Acceptance Test documents, and Site Acceptance Test documents to confirm qualification readiness.

Perform qualification risk assessments and identify critical systems and parameters that may affect product quality or patient safety.

Investigate qualification-related deviations and coordinate timely resolution.

Prepare, review, issue, and maintain validation and qualification documentation in compliance with GMP and document-control requirements.

Coordinate qualification activities with Engineering, Production, Quality Control, Quality Assurance, Validation, project teams, and external vendors.

Support regulatory inspections, customer audits, and quality assessments by providing qualification documentation and technical expertise.

Requirements

Bachelor's Degree in Engineering, Pharmaceutical Science, or a related discipline.

Experience in GMP pharmaceutical manufacturing, preferably within oral liquid manufacturing or a related dosage-form environment.

Working knowledge of qualification lifecycle principles, including DQ, IQ, OQ, and PQ.

Good understanding of GMP, Annex 15, PIC/S guidance, risk-based qualification, and validation principles.

Experience preparing or reviewing qualification protocols, reports, engineering documents, FAT and SAT records, deviations, CAPA, and change-control assessments.

Strong technical-writing, analytical, problem-solving, project-coordination, and documentation skills.

Ability to work effectively with cross-functional project teams and external vendors.

Systematic and detail-oriented approach to qualification execution and technical documentation.

Strong ownership of timelines, follow-up actions, and document completion.

Clear communicator who can coordinate technical activities across departments and vendors.

Hovid (formerly known as Ho Yan Hor) carries with her years of invaluable experience in the pharmaceutical industry.

Dating back to early 1940s, when the business was first established, Hovid's only commodity was Ho Yan Hor Herbal Tea, concocted by its founder, Dr Ho Kai Cheong. With the intention of helping people, Dr Ho Kai Cheong formulated a unique concoction of 24 specially chosen herbs and developed Ho Yan Hor Herbal Tea. It was a popular alternative to western medicine during post World War II with its Cooling and Anti Viral properties. Ho Yan Hor Herbal Tea was the most seek after solution during the Worldwide Flu Epidemic in 1950s. Since then, Ho Yan Hor has become a household name. After 74 years, Ho Yan Hor Herbal Tea still remains as the favorite among many as a natural herbal beverage.

In the 1980s, along with his father's success, David Ho, as a well trained pharmacist, led Hovid into a new chapter of manufacturing excellence. Armed with expertise in pharmacy with strong passion of entrepreneurship, David ventured into mainstream medical approaches. From that point on, Hovid grew to become one of the Malaysia's leading pharmaceutical manufacturers of high quality and innovative medicinal preparations and health supplements with more than 400 products distributed over 50 countries globally.

Listed on the Main Board of Kuala Lumpur Stock Exchange, Hovid spells familiarity and quality among healthcare providers. With the various divisions in the organization that has been established through years of experience, we are able to deliver speed, excellence and above all, Continuous Innovation and Quality.