Sr quality and compliance engineer

About the Role

As a Senior Quality & Compliance Engineer, you will be the process owner for Quality Risk Management within operations at our Chemical Production facility in Geel. This site manufactures active pharmaceutical ingredients (APIs) and plays a critical role in ensuring product quality and patient safety.

You will drive continuous improvement initiatives to optimize quality and compliance, working closely with cross-functional teams and external partners. This role requires strong collaboration, problem-solving skills, and a proactive mindset to influence change and uphold the highest standards of pharmaceutical manufacturing.

Key Responsibilities

• Act as process owner for Quality Risk Management within operations.
• Prepare, facilitate, and document quality risk assessments.
• Lead and/or participate in complex incident investigations and CAPAs.
• Serve as a change agent, implementing clear processes, tools, and metrics to enhance quality and compliance.
• Represent operations as a spokesperson during audits.
• Collaborate with internal and external stakeholders to ensure alignment and compliance.

Qualifications

Education:

• Bachelor’s or Master’s degree in Chemical Engineering, Process Technology, Bioengineering, Industrial Engineering, Chemistry, or equivalent experience in an industrial operational environment.

Experience:

• Proven experience in a chemical manufacturing environment.
• Strong understanding of quality compliance and risk assessment methodologies in a pharmaceutical setting.
• Knowledge of cross-contamination control and Annex 1 guidelines is highly valued.

Skills:

• Excellent project management, planning, and coordination skills.
• Strong collaboration and communication abilities; a true team player.
• Ability to work independently, make decisions autonomously, and deliver results.
• Fluent in English and Dutch (written and verbal).

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

Hybrid Work