Validation Engineer (Fill finish and Lyophilisation) - Hanoi, Vietnam
Leap29
Hanoi, Vietnam
1 ngày trước
source : RIGZONE

Validation Engineer Filling & Lyophilisation - 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

Carry out the validation activities within an aseptic / sterile environment, taking responsibility for creating specific equipment validation strategies specifically through performance qualification scopes of work.

Undertake validation exercises on Lyophilisation units, fillers and cappers. Review / produce supporting validation documentation, as required, as part of a validation exercise.

IQ / OQ / PQ) Write and review validation protocols and reports for new and existing equipment.

Candidate Requirements

  • Degree qualified in relevant discipline i.e. Chemical, Mechanical, Manufacturing etc
  • Minimum 5 years' experience working in validation engineering
  • 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
  • Experience in the process / performance qualification (PQ) of Filling and Lyophilisation equipment
  • Good command of written and spoken English
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