Job opening - Validatie Ingenieur / C&Q SME in Beerse

summary

beerse, antwerpen
permanent
full-time

job category
engineering

job details

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.

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Are you ready to be the technical cornerstone of Pharmaceutical Excellence?

The Role: Impact & Strategy

key responsibilities
Key Responsibilities
- Technical Leadership: Act as the primary technical point of contact for Equipment Qualification files and lead detailed assessments for projects, modifications, and remediations.
- System Ownership: Manage assessments in COMET and KNEAT, ensuring all qualification documents (URS, SRS, SIA, DQ, IQ/OQ/PQ) meet the highest quality standards.
- Project Coordination: Lead core team meetings, manage project flow via Kanban, and collaborate with QA to ensure seamless file approval.
- Mentorship & Quality: Serve as a coach to Qualification Engineers, providing feedback and guiding them through complex deviations or scope changes.
- Compliance Advocacy: Ensure all activities align with global GMP requirements and stay ahead of international regulations to identify "Kaizen" (continuous improvement) opportunities.
qualifications
Your Profile
- Experience: At least 5 years of relevant experience in a pharmaceutical GMP environment.
- Technical Expertise: Strong technical knowledge of aseptic/sterile equipment and processes is essential.
- Education: Ideally, you hold a technical-scientific degree or equivalent through experience.
- Software Skills: Proficiency in KNEAT (paperless validation) is a major advantage; experience with COMET is preferred.
- Communication: Fluent in English; Dutch language skills are considered a significant plus.
- Mindset: You are a problem-solver who values quality, thrives in a regulated setting, and enjoys sharing knowledge with a team.

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