Associate Quality Engineer at Johnson &… · Sassenheim

Associate Quality Engineer Location: Sassenheim, Netherlands 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 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 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 an Associate Quality Engineer position in Sassenheim, Netherlands. The Associate 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. 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. Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA #LI_Hybrid Required Skills: 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 The anticipated base pay range for this position is: €44,700.00 - €70,840.00 Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.