Validation Specialist

Validation Specialist 

Location:  Leiden (5 days onsite)

Janssen Biologics B.V., a member of the Johnson & Johnson Family of Companies is recruiting for a Validation Specialist at the Manufacturing Science and Technology team (MSAT) to be based in Leiden, the Netherlands. 

Leiden site MSAT manages the process technology platform strategy for the production of biotherapeutics and vaccines in Leiden. We are responsible for Validation and Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes!

The role:

The Validation Specialist  is a member of the Manufacturing Science and Technology (MSAT) Team with the dedicated focus on:

• Resin Lifetime program

• (Process) Validation

• Process improvements

Job Description / Responsibilities:

• Define (process) validation strategies.

• Write and review (process) validation protocols and reports

• Responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines and meet the quality requirements

• Ensure integration of the global standards into local production processes

• Act as primary interface between the Leiden site Operations, Quality, BTDS departments and the MSAT organization

• Capable of supporting complex investigations and risk assessments

how to succeed

Education / Experience 

• At least a Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education)

• Manufacturing experience in a biotechnology or biopharmaceutical industry environment, preferably with chromatography columns/resins

• LEAN and CI knowledge

• Good balance in theoretical and practical insights

• Analytical ability and dealing with complexity and detail attentive

• You are critical, proactive, like to work in a team and have E2E mindset

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 Biologics

Janssen Biologics in Leiden, the Netherlands, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Vaccines. We combine our proven strengths with innovation to meet the needs of today and tomorrow. At Janssen Biologics, enthusiastic people are working together in a dynamic culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and commit to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark!

https://www.janssen.com/netherlands/nl

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. 

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 are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each 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”.