Quality Engineer
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Job Location:
Teylingen - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Supply Chain ManufacturingJob Sub Function:
Manufacturing Pharmaceutical Process OperationsJob Category:
ProfessionalAll Job Posting Locations:
Sassenheim NetherlandsJob Description:
About Innovative Medicine
Ourexpertisein 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 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 160000 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:
Bachelors 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.
Heres what you can expect:
- Application review: Well carefully review your CV to see how your skills and experience align with the role.
- Getting to know you: If theres a good match youll 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 well 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. Were excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
Required Skills:
Preferred Skills:
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
