Process Engineer

Location: Leiden 

Hours: 40h 

Hybrid way of working

Imagine your next role as a Process Engineer where you will become part of the Process, Technology, and Projects (PTP) team and strengthen our department with knowledge and expertise of the Drug Product process.

About the department.

This vacancy is for The Gene Therapy Facility. 

The PTP team consists of 12 professionals with in-depth knowledge of specific subjects such as Upstream processing, Downstream processing, Project management, process excellence, and safety. Together, we make sure to have safe, lean, robust, manufacturable, and compliant processes. 

Responsibilities

• Ensure that the implemented process is well-defined and aligned with the operational procedures. For new processes, it means that the (small scale) developed process needs to be evaluated and the changes required within the GTF for the robust and compliant implementation of a manufacturable process are defined precisely.

• Work closely within the Technical Transfer team to ensure that the (development) knowledge is accurately transferred into the process and operational documentation. In addition, you will collaborate with PTP members in other expertise areas, the manufacturing specialists (system owners), operators, and GMP specialists.

• Will be the interface and do stakeholder management with MAKE Asset Management (MAM), clinical, regulatory, and quality departments, the Value Chain team, and the GTF management team. 

• Will be a single point of contact (SPOC) for the site tender team for drug product processes in the GTF.

• Support production of cGMP batches for exiting processes in the GTF in the area of drug products. 

• Initiate and handle compliance records (change control, CAPA, deviations), including investigation of major deviations for potential product impact, root cause investigations of complex deviations, evaluation of changes before implementation and data gathered post-implementation to prove that the change had the desired effect.

• Have the overview and knowledge of the status of the process, including ensuring the stability of critical parameters, ongoing investigations, registered process, and analysis of ongoing process data. 

• Identify and conceptualize (process) improvements to increase the speed, reliability, yield, or capacity of the process, define scope and deliverables, and lead or be a member of a team to implement agreed change and realize the agreed goal.

• Lead or are key members in projects involving process changes and implementation of (enabling) technologies, including Digital Technologies. 

• Will be the interface with the product owners (MSAT or R&D), regulatory and value chain departments, and work with MAKE Asset Management (MAM).

To be successful in this role you have:

• Bachelor/master’s degree in biotechnology, biochemistry, biomedicine, or process technology (or equivalent education or experience).

• Proven experience in a biotechnology or biopharmaceutical industry environment, in a cGMP environment, and with EHSS standards.

• In-depth, up-to-date knowledge of Drug Product processes.

• Fill & Finish drug product process (sterilization and standardization of medical materials) 

• Excellent communication in English, verbally and in writing. 

• You are proven resilient. You can deal with challenges, changes, and unexpected setbacks in a positive and meaningful way.

• Project management skills.  

• Certified (Lean) Green Belt 

• Good understanding of regulatory requirements and industry guidelines specific to the pharmaceutical manufacturing industry (e.g. GMP, Annex 1, etc.). 

benefits

This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for 6 months with an opportunity later for a direct contract with Johnson & Johnson.

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

If you meet our requirements and are interested in hearing more about our NPI Coordinator role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!

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”!