Laboratory Operations Project Engineer
Solliciteren
Plaats
Sint-Amands2890
Antwerpen
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-02-21Online to:
2026-04-22EUR 20.00 HOUR
Laboratory Operations Project Engineer
- Pauwels Consulting
- Antwerpen
- 10 uren geleden
Our client, a prominent pharmaceutical organization, is seeking a Laboratory Operations Project Engineer to manage compliance assessments for method validation and compendial dossiers. The role focuses on the implementation of new test methods within Quality Control operations while coordinating project activities and ensuring technical documentation standards.
Assess the compliance of method validation and compendial compliance dossiers within a regulated framework.
Implement new test methods and procedures in Quality Control operations, ensuring alignment with project timelines.
Write and review technical protocols, testing scripts, and validation reports.
Manage analytical deviations and perform root cause analysis using methodologies like DMAIC.
Validate analytical data files, including SoftMaxPro and Excel, to maintain data integrity.
Provide technical support to analysts during test execution and perform troubleshooting for laboratory issues.
Initiate corrective and preventive actions to address quality-related deficiencies.
What are we looking for?
You have a Master's degree in Bio-engineering, Industrial Pharmacy, Biochemistry, Biotechnology, or a related scientific field.
You bring 1+ years of experience within a GMP environment, preferably in a pharmaceutical or production setting.
You possess strong technical writing skills for the creation and review of validation protocols and reports.
You have experience with root cause analysis and the initiation of CAPA within a quality control context.
You're recognized for your analytical thinking, problem-solving abilities, and strong organizational skills.
You are fluent in Dutch with a good knowledge of English.
Nice to Haves
Experience validating files in SoftMaxPro or specialized laboratory software.
Willingness to obtain experience in co-authoring regulatory submissions for new medicines or vaccines.
Assess the compliance of method validation and compendial compliance dossiers within a regulated framework.
Implement new test methods and procedures in Quality Control operations, ensuring alignment with project timelines.
Write and review technical protocols, testing scripts, and validation reports.
Manage analytical deviations and perform root cause analysis using methodologies like DMAIC.
Validate analytical data files, including SoftMaxPro and Excel, to maintain data integrity.
Provide technical support to analysts during test execution and perform troubleshooting for laboratory issues.
Initiate corrective and preventive actions to address quality-related deficiencies.
What are we looking for?
You have a Master's degree in Bio-engineering, Industrial Pharmacy, Biochemistry, Biotechnology, or a related scientific field.
You bring 1+ years of experience within a GMP environment, preferably in a pharmaceutical or production setting.
You possess strong technical writing skills for the creation and review of validation protocols and reports.
You have experience with root cause analysis and the initiation of CAPA within a quality control context.
You're recognized for your analytical thinking, problem-solving abilities, and strong organizational skills.
You are fluent in Dutch with a good knowledge of English.
Nice to Haves
Experience validating files in SoftMaxPro or specialized laboratory software.
Willingness to obtain experience in co-authoring regulatory submissions for new medicines or vaccines.
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