Method Validation Engineer

Location: Belgium

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Oost-Vlaanderen Belgium.

The Company

Our client is one of the leading CDMOs in Europe providing high-quality, customized drug development solutions for specialty and biopharma clients. Their focus is to support clients on the earliest phases of their development pathway (from API to the clinical packaging).

Its Belgian subsidiary is based in Ghent, offering a complete drug development package for new drug entities (biological and chemical) up to early clinical phases to third parties to help them in speeding up the development and manufacturing of their drugs. To support their ambitious growth plan, they are looking for a Method Validation Engineer for the site in Ghent, Belgium.

Role Description

The Belgian subsidiary wishes to enforce its team with a Method Validation Engineer. The Method Validation Engineer reports to the QC Manager.

Responsibilities

Key responsibility: you are responsible for the validation of analytical methods to support the quality control testing of Drug Products used in clinical trials.

- You interact with Analytical Development and Project management in preparation of validating the different analytical methods needed for the Drug Product Release and stability
testing.
- You write Validation Protocols in accordance with international recognized guidelines (ICH, FDA, Ph. Eur., USP).
- You execute and follow-up the execution of the Validation Protocol in compliance with the GMP principles and the procedures of the Eurofins Quality Management System.
- You calculate, review and summarize the analytical test results in Validation Reports.

Requirements

- Master Degree with a scientific orientation (e.g. Analytical Chemistry or Pharmaceutical sciences) with a first profound professional experience, preferably in a pharmaceutical setting.
- Key scientific knowledge: in-depth knowledge of Liquid Chromatography is a must (Waters U(H)PLC systems; UV/ELSD detectors and Empower CDS).
- Proven record of accomplishment in analytical method validation.
- Experience within a GMP environment is a major asset.
- Experience with Karl Fischer, Dissolution, UV spectroscopy and Laser diffraction techniques provide added value.
- Able to work independently after training in matters entrusted to you.
- Team player with strong organizational and communication skills
- Problem solving, flexible mindset whilst being punctual and quality driven.
- Professionally fluent in English (written and spoken)- MS office adapted

Other information

- A position with responsibility within a dynamic company.
- You will join a mix of young and experienced analysts and project leaders.
- Personal development through learning on the job and additional external trainings
- A market oriented compensation based on your relevant experience.

Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Rutger Koning