Company: Leap29
Skills: Chemist
Experience: 5 + Years
Education: Bachelors/3-5 yr Degree
Employment Type: Full Time Contractor
Location: Hanoi, Vietnam


QC Validation Engineer - Vaccine Facility (Technology Transfer) - Hanoi, Vietnam

The Location: Hanoi, Vietnam
Duration: 6 to 12 Month Contracts
Working Week: 60 hours a week - 6 days a week - Monday to Saturday
Package: Competitive base rate, Accommodation, Transport and per diem.

The Company

A turnkey process engineering consultancy with 500+ employees, 20+ offices situated across Europe, Asia, and the middle east. This company focus on a wide scope of engineering services, completing projects in Pharmaceutical, Food and Beverage, Semiconductors, Data Centres and Specialized Technologies.

The Project

This work is on a hyper fast tracked technology transfer project for an mRNA fill-finish facility designed to produce around 200m lyophilised doses per year. The facility occupies just under 9,000m2 in built-up area. The project value is in the range USD50 to 75m.

Duties / Responsibilities

Direct responsibility for decision making, problem solving through root cause analysis and implementing corrective actions
Planning and prioritising own workload to ensure agreed deadlines are met including coordinating and performing validation activities along with tracking and reporting of progress to the Validation, QA and Process Leaders
Maintaining validated status by fulfilling re-validation and re-evaluation commitments
Providing technical leadership on issues and leading the project team to overcome challenges
Creating, executing and reporting validation documentation
Providing an analytical method approach to the quality control of the validation processes and procedures

Candidate Requirements

• Degree qualified in relevant discipline i.e., Chemical, Mechanical, Manufacturing etc
• Minimum 5 years' experience working in validation engineering
• Experience gained in pharmaceutical manufacturing projects or projects under GMP guidelines
• Ideally based in the Southeast Asian region and able to start within one or two months .
• Good Knowledge of cGMP, GAMP and understanding of pharmaceutical regulatory requirements
• QC laboratory equipment validation experience
• Good command of written and spoken English




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