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Gepubliceerd 15 april Qiality Engineer

Yacht Life Sciences has a vacancy for a Quality Engineer to work at Johnson & Johnson Innovative Medicine in Leiden.

Your main tasks as a Senior Associate Engineer:

• Lead medium and high impact quality investigations (QIs) and root cause investigation, including CAPA records Act as change control (CC) lead for operations by being responsible for the change control from initiation through completion.
• Support process changes arising from updates to materials, equipment, facility and biotherapeutic products including new product introduction.
• Drive quality improvement projects within Operations Biotherapeutics in close collaboration with the stakeholders Act as a Subject Matter Expert on deviations/change controls during inspections and audits.
• Ensure compliant documentation and accurate completion of quality records Monitor progress and KPIs for QI/CC process.
• Lead process excellence activities to continuously improve the work as well as personal skills.

Functie-eisen

Job requirements

• Bachelor or master’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• >2 years relevant work experience in a biotechnology or biopharmaceutical industry environment
• GMP experience
• Previous experience with change controls or quality investigations (pre)
• Experience with Trackwise QEM (pre)
• Strong affinity / knowledge of operating systems and instrument software

Competenties

Competencies

• Analytical ability, capability to take care of complex issues.
• Flexible, can deal with changing priorities.
• Innovative: Continuous innovation of the work processes and working environment.
• Excellent interpersonal skills, written and oral in English (required) and Dutch (pre).

Arbeidsvoorwaarden

Terms of employment
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.

This concerns a secondment contract for 1 year via Yacht. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefits package in line with your seniority and the seniority of the position. Salary between 3800 and 4950 gross per month.

Bedrijfsinformatie

About the Company
At Johnson & Johnson Innovative Medicine, they are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure diseases inspires us. They bring together the best minds and pursue the most promising science.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Why YACHT Life Sciences?
Because of challenging positions at leading (biotech) companies, a large network and development opportunities! These are the advantages of working via YACHT in general and YACHT Life Sciences in particular.

With us, you will get all the space to grow further. Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.

Through us, you will get access to a network of professionals and companies that are happy to share their knowledge and opportunities with you.

Inclusiviteit en diversiteit

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.

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