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Are you ready to be the technical cornerstone of Pharmaceutical Excellence? In the world of life sciences, precision isn’t just a goal—it’s a requirement. As our new C&Q Subject Matter Expert (SME), you won’t just be 'checking boxes.' You will be the guardian of compliance and the technical driving force ensuring that our equipment and utilities deliver products that change lives. If you are a seasoned expert in aseptic processes who thrives on technical ownership and coaching others, your next career milestone starts here. The Role: Impact & Strategy As the C&Q SME, you act as the Technical Owner within the IM SC Beerse organization. You are the bridge between complex engineering projects and strict regulatory compliance. You will provide the documented evidence that our systems remain in a state of control, while coordinating high-level qualification activities that keep our production safe and efficient.
Job Responsibility:
Act as the primary technical point of contact for Equipment Qualification files and lead detailed assessments for projects, modifications, and remediations
Manage assessments in COMET and KNEAT, ensuring all qualification documents (URS, SRS, SIA, DQ, IQ/OQ/PQ) meet the highest quality standards
Lead core team meetings, manage project flow via Kanban, and collaborate with QA to ensure seamless file approval
Serve as a coach to Qualification Engineers, providing feedback and guiding them through complex deviations or scope changes
Ensure all activities align with global GMP requirements and stay ahead of international regulations to identify 'Kaizen' (continuous improvement) opportunities.
Requirements:
At least 5 years of relevant experience in a pharmaceutical GMP environment
Strong technical knowledge of aseptic/sterile equipment and processes
Ideally, you hold a technical-scientific degree or equivalent through experience
Proficiency in KNEAT (paperless validation) is a major advantage
Experience with COMET is preferred
Fluent in English
Dutch language skills are considered a significant plus
You are a problem-solver who values quality, thrives in a regulated setting, and enjoys sharing knowledge with a team.
Nice to have:
Dutch language skills are considered a significant plus
Proficiency in KNEAT (paperless validation) is a major advantage