Change Control Specialist

Change Control Specialist

Location: Leiden 

Duration: 6 months contract 

Hours: 40h 

Hybrid way of working   

Imagine your next role as a GMP (Change Control) Specialist which you will be responsible for the well-structured approach and the progress of GMP Change Controls. 

Summary of your role

You will be the first line of support of the Change/Project Lead, coordinating and facilitating Change meetings and ensuring that progress is documented in a compliant way.   Additionally, you will also work on the maintenance and improvement of general GMP processes, as needed. Examples are support in Quality Deviations and CAPAs, Training, updating general GMP procedures, support in inspections, etc. You collaborate closely with the operations department, the equipment owners, the process engineers, and other staff members of the VLF. Also, you are a key contact for and work closely with the Quality Department.   During the preparation phase (the transfer of new products to the VLF in 2024) you will work mainly on writing change controls for the introduction of new processes.

About the department 

The operations department is responsible for on-time manufacturing and delivery of the planned batches against the high-quality standards and safety and compliance regulations that are applicable for Janssen’s product portfolio for Gene Therapeutic products. The operation department consists of Manufacturing operators and specialists. 

The Manufacturing Operators are responsible for the actual on-time production, filling, and delivery of the products. The General Operations Team consists of Manufacturing specialists, GMP specialists, a planner, and Operations Engineers with in-depth operation knowledge and are responsible for GMP, inspections, planning, and project support within the operation department and the other departments. 

Main Responsibilities

• Writing change controls for the GMP/EHS systems and VLF improvements, and responsible for follow-up and timely documentation and completion.

• Set up a Change Control strategy for change controls and planning for projects. 

• Supporting the change lead in ensuring that all relevant GMP input is gathered and documented. 

• Assist in developing/implementing the tools needed to ensure that change controls are documented and executed in a compliant cGMP manner. Train experts across the VLF as needed.

• Collaborate with the QA department to ensure continuous improvement and standardization of the Change Control process.

The ideal candidate for this position should have:

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

• Proven experience in a biotechnology or biopharmaceutical industry environment. 

• Good communication skills in Dutch and English, both verbally and in writing.

• Experience in Quality Systems, specifically Change Control.

• Working knowledge of cGMP standards.  

• A preference for experience with Trackwise QEM, Truvault or similar automated systems.

• Knowledge and experience with Lean methodology and Six Sigma. 

• Resilient and stress-resistant: Maintains composure under pressure, handles setbacks effectively, and confidently manages deadlines while prioritizing quality and feasibility.

• Collaborative with an improvement mindset: Fosters a positive learning culture, actively engages with team members, and seeks collaborative solutions for achieving optimal performance and results.

benefits

This role offers a very competitive hourly rate & a supportive working environment. This contract will run for 6 months. 

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/vaccines-r%26d-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. 

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”!