Vacancy number: A2500053
Johnson & Johnson Innovative Medicine - Leiden (Nederland)
For our client, Johnson & Johnson Innovative Medicine, we are looking for a Quality Engineer.
Johnson & Johnson Innovative Medicine - Leiden (Nederland)
For our client, Johnson & Johnson Innovative Medicine, we are looking for a Quality Engineer.
Keywords
- Quality Investigations (CAPA & Change Control)
- GMP Compliance
- Analytical Problem-Solving
- Continuous Improvement
- Stakeholder Collaboration
Profile
As a Quality Engineer, you play a key role in supporting operational excellence by ensuring compliance with quality standards, regulatory requirements, and company policies. You are responsible for both routine and complex quality activities, co-ordinating cross-functional teams when needed, and driving continuous improvement initiatives. With strong communication skills and professional judgement, you act as a trusted partner to both internal stake holders and external customers.In this role you:
- Apply in-depth knowledge of quality requirements to support the achievement of operational objectives;
- Conduct non-conformance investigations, manage CAPA records, and lead change controls from initiation to closure;
- Review documentation related to processes and activities for operational products, ensuring accuracy and compliance;
- Maintain and update procedures based on regulatory requirements, investigations, and audits;
- Ensure quality records are compliant, accurate, and completed on time;
- Identify risks, propose mitigations, and implement continuous improvement projects under limited supervision;
- Support escalation processes to provide visibility on risks related to safety, product quality, and compliance;
- Perform GEMBA walks to monitor GMP adherence on the production floor, document findings, and work with teams to implement improvements;
- Take ownership of personal training and contribute to building an inclusive, collaborative team culture.
- Provide subject matter support during inspections and audits, particularly for non-conformances and change controls;
- Contribute to the development of cGMP training programs and support audit/inspection responses;
- Perform data analyses on recurring non-conformances to recommend corrective actions.
Who we're looking for
The ideal candidate holds a relevant BSc. degree and brings at least 3 years of experience in a comparable Quality role. You are fluent in English and confident with IT tools, showing intermediate proficiency in MS Office, routine capability in data analysis, and specialist skills in business applications.You combine a positive, proactive, and decisive mindset with strong organisational skills. Stress does not distract you; you remain calm, accurate, and quality-focused under all circumstances. Flexibility and the ability to manage shifting priorities are key strengths, and you take accountability by addressing issues proactively and ensuring follow-through on results.
Analytical thinking is central to your work: you know how to deal with complexity, ask the right questions, identify data gaps, and perform root cause analyses. Creative problem-solving and thinking outside the box help you to drive effective solutions. You prioritise tasks effectively to meet deadlines and maintain strong stake holder alignment, building meaningful connections with internal and external partners.
Experience in leading or significantly contributing to change controls and quality investigations is required. Finally, you are a team player who values constructive feedback, fosters collaboration, and contributes to continuous improvement initiatives that support both team and personal growth.
Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
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Additional vacancy information
| Reference | : | A2500053 |
| Contract | : | Temporary contract with CLS Services |
| Education | : | HBO/BSc. |
| Employment terms | : | Project for at least 1 year Salary: 44-60k Days of leave: 36 See here our other employment terms for this vacancy. |
| Publication date | : | 26-9-2025 |
| Location | : | View location with Google Maps |
| Contactperson | : | René Kemps |
| +31 (0)88 22 77 555 |
CLS Services is a leading professional recruitment agency, specialised in the recruitment and secondment of people with a background in chemistry & life sciences.
