Quality Engineer

Janssen Biologics is currently seeking a (associate) Quality Engineer in Leiden.

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 https://www.jnj.com/

Looking for a junior or senior role in the heart of biologics production in Leiden? Then look no further! In the role of (associate) Quality Engineer you will take ownership for the medium and high impact quality investigations on the different commercial and late-stage clinical products.

What you will be doing:

The role of (associate) Quality Engineer is to take ownership for the medium and high impact quality investigations on clinical products, root cause investigation, including CAPA records. In other words, you ensure that patients around the world get treatment of the highest quality!

What impact you will also have:

• 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, which includes to lead the process excellence activities to continuously improve the work as well as personal skills.
• 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 and monitor progress and KPIs for QI/CC process;
• Act as a Subject Matter Expert on deviations/change controls during inspections and audits and ensure compliant documentation and accurate completion of quality records.

Qualifications

We would love to hear from you, if you have the following essential requirements:

• Bachelor 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)
• Excellent interpersonal skills, written and oral in English (required) and Dutch (pre).
• Analytical ability, capability to take care of complex issues.
• Flexible, can deal with changing priorities.

Whats in it for YOU:

• Referral Bonus
• Working Jubilee Gift
• Marriage gift
• Global Parental Leave
• Bike Plan
• Fitness allowance
• Commute allowance max 26km per day
• J&J Pension plan
• J&J Health insurance
• 36 days Holidays/Leave
• Flexible working hours

What type of mark will YOU make?

By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"!

For more than 130 years, diversity, equity & inclusion 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.