260 days ago on sire-search.com

Qualification & Validation Engineer

SIRE Life Sciences

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Qualification & Validation Engineer

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!


Our client is a professional Biotechnology, Medical Devices and Pharmaceutical organization, based in Basel-Stadt Switzerland.

Our client is a large Healthcare company.


Practical realization of the project work in line with established procedures (MBRs,SOPs) and regulations (cGMP, ICH)
Documentation of experiments and / or GMP CTM productions and results according to procedures
Evaluation of results together with the senior position
Responsible for writing (parts of) study plans, study reports, SOP's
Implementation of new techniques and technologies
Internal organization of the lab or cleanroom, including GXP and HSE aspects
Actively participate in the integration of cGMP compliance, process excellence and process development aspects of CTM
Stay up to date on novel technologies related to the work area
Communication with external parties for purchasing and commissioning of new equipment
Trouble shooting / solving
Actively participate in the integration of cGMP compliance, process excellence and process development aspects of CTM


Specific process-related responsibilities / accountabilities
Execute experiments or productions according to predefined Study Plans or batch records
Development / qualification / validation
USP / DSP/Formulation processes
Stability / Comparability studies
Characterization /(Pre) Process Robustness/Fill & Finish
Production or testing of master/working cell bank, tox material, reference material, drug product and drug substances


MSc/BSc level or equivalent in Bio-Process Engineering / Biotechnology
Applicable scientific/technical background in biotech for the areas of expertise
Several years of relevant experience as technician or equivalent in a cGMP / development environment
Communication skills and basic project management
Precision Independency, adaptability organisational commitment
Analysis planning & organizing, self-awareness, result-orientation
Coaching, High-impact delivery
Language proficiencies: -English and German spoken and written;

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