Quality Engineer

Janssen Biologics B.V., part of Johnson & Johnson, is setting up a new production facility in Sassenheim. This new facility will produce lentiviral vectors (LVV), which are used in the treatment of multiple myeloma, a disease affecting 160,000 patients globally. The team is preparing for commercial production in 2026. Therefore, we are searching for the best talent for a Quality Engineer position in Sassenheim, Netherlands.

The Quality Engineers are integral members of GMP department, which is part of Lentiviral Operations (LVO). The GMP department is crucial in supporting both the Operations (Ops), Centre of Expertise (CoE) and New Product Introduction (NPI) departments, particularly regarding GMP compliance (including Annex 1, Training and Quality Risk Assessments), non conformances and change controls. We always adhere to high-quality standards, safety, and compliance regulations applicable to LVV manufacturing.

You will be responsible for:

• Leading deviations and root cause investigations, ensuring timely follow-up and completion of non-conformance records.
• Writing and facilitating change controls to document introductions and changes in GMP production processes.
• Reviewing general LVV GMP documentation and delegating improvements to keep GMP compliance up-to-date.
• Participating in, leading and/or facilitating quality risk assessments (QRA).
• Coordinating, supporting, and preparing activities during internal and external audits in the role of Primary Contact, Subject Matter Expert (SME), scribe, or back-office lead.
• Coordinating internal batch release.

Qualification and Requirements:

• Bachelor’s or University degree in Science or Engineering preferred.
• 2-8 years’ experience in a biotechnology or biopharmaceutical (GMP) production environment.
• Strong working knowledge of current Good Manufacturing Practice (cGMP) standards is essential; familiarity with Annex 1 regulations is preferred.
• Experience with quality systems (e.g., Comet, TruVault).
• Proficiency in Microsoft tools: Excel, Visio, SharePoint, Word, and PowerPoint.
• Excellent communication skills in English; additional Dutch language skills are preferred.
• Strong influencing skills and excellent stakeholder management within a highly complex matrix organization.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility

Hybrid Work