Validation Expert
$52,200–$96,900 year
On-sitePuurs, Flanders, Belgium
Job Summary
Manage qualification status of validated process equipment and processes, including modification activities to comply with cGMP requirements. Prepare and verify process requalification protocols and reports with meticulous attention to detail, planning and executing periodic initiatives for sterilisation, cleaning, and aseptic process simulations. Ensure all activities adhere to current regulatory requirements, proactively manage deviations, and maintain a state of audit/inspection readiness. Conduct risk assessments and collaborate with cross-functional teams to analyse and mitigate process risks. Requires a Scientific/Engineering Degree, previous GMP manufacturing experience, and fluency in English and Dutch. Hybrid work options available at Puurs.
Required Qualifications
- Scientific/Engineering Degree
- Previous experience within Quality/MS&T/Production department of a GMP manufacturing site
- Proactivity
- Flexibility
- Fluent in English
- Fluent in Dutch
Desired Qualifications
- Assembly Language (ASM)
- Change Controls
- Chemical Engineering
- Chemistry
- Continual Improvement Process
- Cost Reduction
- Data Analytics
- Electronic Components
- General Hse Knowledge (Inactive)
- Including Gdp (Inactive)
- Knowledge Of Capa (Inactive)
- Knowledge Of Gmp (Inactive)
- Lean Manufacturing
- Manufacturing Processes
- Manufacturing Production
- Pharmaceutics
- Process and Cleaning Validation (Inactive)
- Process Control
- Process Engineering
- Risk Management
- Root Cause Analysis (RCA)
- Six Sigma
- Standard Operating Procedure (SOP)
- Workforce Planning
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