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Senior validation engineer (Supply chain)

SIRE Life Sciences®

Belgium, zagranica

SIRE Life Sciences®

Senior validation engineer (Supply chain)

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Henegouwen Belgium.

The company focuses on the patients who struggle with rare diseases. They are a global organisation that is sharply focused on developing new medicines.

ROLE DESCRIPTION

In this role as senior global distribution validation engineer you play a big part in getting the products safely all around the world. You will work closely with the supply chain ,QA en CMO department to look for opportunities to improve the existing systems processes and Performances. Support Internal and external GMP audits related to shipping validation. Support regulatory fillings for new product launches. In this role you will develop and implement standards and SOPs for supporting the assessment, qualification, implementation, continuous improvement and life-cycle management of all distribution solutions (systems and processes).

RESPONSIBILITIES

Responsible for assuring that the products are transported under proper conditions and that shipping systems and processes are qualified in compliance with their Quality and Regulatory Agencies requirements. Responsible for GDP compliance on shipping systems and processes and act as SME of thermal packaging. Next to that you will be responsible for the following:
Maintain validation master plans
Monitoring end-to-end performance of shipping solutions, perform trending analysis
Assessing Vendor data (OQ)
Performing shipping qualification studies (PQ)

REQUIREMENTS

- Bachelor’s or Master Degree in engineering
- Minimum 4 years of related experience
- Fluent in English (written and spoken)
- excellent experience with logistic validation and thermal packaging engineering validation
- Experience with GDP (distribution) and proven knowledge and application of cGMP requirements and demonstrated application of industry guidance/standards document (e.g., ISTA, ASTM, ISPE, PDA, ISO, ICH, Pharmacopeias) and Regulatory CMC guidance documents applicable to the role
- Experienced with multiple PM tools and processes
- High level of MS office tools (Word, ppt, excel, access, project)

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.

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SIRE Life Sciences®

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