Validation Engineer

Looking for a challenging role where you can make a real impact ?Passionate about aseptic validation? Drive innovation and compliance by crafting critical validation protocols and SOPs that keep our sterile manufacturing world-class!

As a Validation Engineer, you will lead engineering projects within pharmaceutical manufacturing, with a primary focus on aseptic compounding and filling. You are responsible for creating, managing, and implementing validation and qualification protocols, SOPs, and work instructions that ensure compliance and quality of aseptic processes. You will work closely with project teams to ensure all technical and regulatory requirements are fully integrated into project documentation and execution.

💡 Your mission:

• Lead engineering projects in the aseptic production environment, including aligning on project definitions, priorities, and necessary resources.
• Write, review, and manage validation and qualification protocols (VMP, URS, DQ, IQ, OQ, PQ), SOPs, and work instructions specifically for aseptic compounding & filling processes and equipment.
• Prepare project intake documentation, including scope, business case, and risk assessment, and present options for project approval.
• Plan, track, and report project progress and results to all relevant stakeholders.
• Manage project budgets and ensure efficient use of resources throughout the project lifecycle.
• Apply risk management methodologies to identify and mitigate potential risks to project objectives.
• Ensure compliance with all relevant Environmental, Health, Safety, and Sustainability (EHSS) standards.

🔍 What about you:

• Master's degree in engineering.
• At least 5 years of experience in a GMP - industrial production environment. Experience with aseptic production processes and their validation is a strong advantage.
• Proven experience in writing and managing validation and qualification protocols, SOPs, and work instructions.
• Knowledge of risk-based qualification methodologies (e.g., FMEA) is a plus.
• Strong organizational and project management skills.
• Good communication skills in both Dutch and English.
• Hands-on mentality with willingness to work flexibly in sterile production environments.
• Ability to work both independently and as part of a team in a dynamic environment.

🌟 Why join us:

• Be part of a 100% Belgian independent company, specializing in the life sciences sector.
• Work in a supportive, friendly team that is committed to your growth and success.
• Contribute to a meaningful project with a direct impact on health and people's quality of life.
• Enjoy a career with growth opportunities in a dynamic and innovative environment because we believe in your potential !
• A competitive benefits package that includes company car, meal vouchers, and health benefits, … We’ve got you covered!

Ready to be a part of this exciting project ? Apply now, we’re excited to meet you!