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Qualification & validation engineer

Louvain
MindCapture
Publiée le Publiée il y a 5 h
Description de l'offre

Passionate about Qualification & Validation? Take the lead in ensuring high-quality pharma manufacturing processes and equipment.


What is offered

Ready to grow your career and make real impact? Join MindCapture!

We offer competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance, and a company car) — plus the opportunity to shape your future through personalized training and development.

At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most.


You will work as a MindCapture consultant for an international market leader in the pharmaceutical industry.


Job Description:

As a Qualification & Validation engineer, you will play a key role in ensuring that pharmaceutical equipment, processes, and systems meet the highest standards of quality, compliance, and regulatory requirements.


Depending on your background and seniority, you will be involved in:


* Managing equipment qualification and validation activities across solids, parenterals, or API manufacturing.
* Preparing and executing URS, DQ, IQ, OQ, PQ protocols and risk assessments (FMEA, validation master plans).
* Leading or supporting project management for the introduction, modification, and lifecycle management of pharmaceutical equipment (e.g., filling lines, lyophilizers, CIP/SIP systems, sterilizers, nano-milling).
* Performing and reviewing aseptic process simulations (media fills, re-validations).
* Documenting and defending qualification and validation approaches towards QA and regulatory stakeholders.
* Ensuring strict adherence to GMP/GDP, compliance, and data integrity requirements.
* Supporting continuous improvement initiatives and troubleshooting of technical and process-related issues.


Requirements:


* Master’s degree in Engineering, Life Sciences, or related field (or equivalent through experience)
* 3–10+ years of experience in qualification & validation within the pharmaceutical/biotech sector
* Strong knowledge of GMP, GDP, and regulatory compliance
* Hands-on expertise with equipment qualification and validation protocols (URS, DQ, IQ, OQ, PQ)
* Experience with risk assessments and validation documentation (VMP, CAPA, CC management in COMET or equivalent systems)
* Knowledge of parenteral processes and/or API/solid manufacturing is a plus
* Familiarity with computerized systems (COMET, SAP, eLIMS, MS Project, Minitab)
* Languages: Fluent in Dutch and English (spoken & written)
* Strong project management, organizational and coordination skills
* Analytical mindset with problem-solving abilities and quality & compliance focus


Are you ready to make a real difference in healthcare?

Join our dynamic team and help drive innovation in pharma.


Apply now and let’s make an impact together!

Want to learn more? Discover all opportunities at www.mindcapture.com.

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