Laboratory Operations Project Engineer
Antwerp
Life Sciences - Lab
Master
Work experience: 0-3
Reference number: 93629
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.
Your responsibilities:
- 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.
What do we offer?
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
)
