Quality Engineer

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Supply Chain Manufacturing

Job Sub Function:
Manufacturing Pharmaceutical Process Operations

Job Category:
Professional

All Job Posting Locations:
Sassenheim, Netherlands

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Janssen Biologics B.V., part of Johnson & Johnson, is setting up a brand-new production facility in Sassenheim, where we will produce lentiviral vectors (LVV) used in the treatment of multiple myeloma, a disease affecting 160,000 patients globally, with commercial production targeted for 2026.

This is a unique opportunity to help build a state-of-the-art site from the ground up.

We are looking for a Quality Engineer to join us on this journey in Sassenheim, Netherlands.

The Quality Engineers are integral members of the GMP department, part of Lentiviral Operations (LVO), supporting Operations (Ops), Centre of Expertise (CoE) and New Product Introduction (NPI) on GMP compliance (including Annex 1, Training and Quality Risk Assessments), non conformances and change controls.

As a Quality Engineer, you will:



* Lead and complete non conformance investigations, CAPA records, and change controls from initiation to closure, ensuring timely, compliant outcomes.


* Participate in reviewing, maintaining, and updating quality documentation and procedures to ensure compliance with regulatory requirements and internal standards.


* Perform regular GEMBA walks and operational observations to identify gaps in GMP adherence and drive corrective actions with the production team.


* Escalate risks and issues clearly and promptly to ensure visibility and timely resolution across stakeholders.


* Initiate and run risk mitigations and continuous improvement projects that reduce recurrence and improve...