Johnson & Johnson
Quality Engineer
Location: Leiden
Duration: 12 months contract
Hours: 40h
Hybrid way of working
Imagine your next role as a Quality Engineer where you will take ownership of the medium and high-impact quality investigations on the different commercial and late-stage clinical products. In other words, you ensure that patients around the world get treatment of the highest quality!
Responsibilities
Lead medium and high impact quality investigations (QIs) and root cause investigations, 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.
To be successful in this role you have:
Bachelor's or master’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
Minimal of 2 years relevant work experience in a biotechnology or biopharmaceutical industry environment (in case of Quality Engineer)
Analytical ability, capability to take care of complex issues.
Flexibility & ability to deal with changing priorities.
Innovative mindset
Previous experience with change controls or quality investigations
Experience with Trackwise QEM
Excellent interpersonal skills, written and oral in English & Dutch are required.
benefits
This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for 12 months. 32h per week is possible.
you are welcome here
Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.
about Janssen
Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen.
https://www.janssen.com/netherlands/nl/janssen-nederland/biologics-leiden
application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
questions
If you would like some additional information about the role please contact: katerina.alikaridou@randstadsourceright.nl
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!