Quality Engineer

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

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 GMP Specialist/Quality Engineer position in Sassenheim, Netherlands.

The GMP Specialist/Quality Engineer is responsible for GMP-related tasks in BU5 and supports the BU5 organization with specialized, in-depth knowledge and skills regarding GMP processes, systems, and compliance. This role requires the ability to devise effective solutions while collaborating and aligning with various stakeholders.

GMP Specialist/Quality Engineer are integral members of the broader Centre of Expertise (CoE) department. The CoE is crucial in supporting both the Operations (Ops) and New Product Introduction (NPI) departments, particularly regarding technical processes and GMP compliance (including Annex 1). The CoE plays a key role in translating developed processes into workable processes for the shop floor. The CoE always adheres 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 and 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.

Here’s what you can expect:

• Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

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