Johnson & Johnson / Viral Launch Facility / OPERATIONS is looking for a senior operator, building our drug product capability
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without diseases. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and hearts to pursue the most promising science into life changing product for patients around the globe. One of the key focus area’s for Janssen in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.
At the Janssen site in Leiden (located at the Bioscience Park), we work with more than 2400 talented and multi-skilled people in 5 different business units. We produce different product and pioneer solutions to deliver better health. This vacancy is for Business Unit 2: The Viral Launch Facility (VLF).
The VLF is Janssen’s state-of-the-art GMP manufacturing facility from which we launch and grow new and innovative Gene Therapeutic products. The facility has two manufacturing suites. In suite 1 we produce Drug Substance (e.g. cell & virus cultivation and purification processes) and in suite 2 we produce Drug Product (e.g. Fill & Finish processes) for the final product.
Both production suites in the VLF are currently in the final stage of preparation for Phase 3 and commercial production to accommodate the transfer of new products to the VLF per 2024.
Are you excited to set up a plant with new equipment and scale up the processes within a global company? Do you get energy from working together and contribute to improve the life of patients?
Then this is your job!
You will become part of the Operations department. This 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 is divided into different teams. There are manufacturing teams for Drug Substance production and manufacturing teams for Drug Product filling, consisting of Manufacturing operators. The Manufacturing Operators are responsible for the actual on-time production, filling and delivery of the products.
Additional there is a General Operations Team consist 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 operations and the other VLF departments.
The core task of the Drug Product department is the filling of the (end) product in vails, package the vails and transport the product. We use different techniques to carry out the entire process. You will work under extremely high GMP standards. Equipment will be used in isolators and the filling process will be an automatic process with a robot.
Responsibilities & impact that YOU have:
The core tasks of a Senior Manufacturing Operator DP consist of:
· Cooperating in the execution of the core tasks and the supporting, routine activities of the department . These core tasks are performed according safety guidelines and a detailed work instruction, after which the completed process actions are immediately noted in the relevant documentation (batch record) and computer systems.
· Monitoring progress and checking whether the activities are being carried out correctly:
- Is the point of contact for production-related questions within the team.
- Signals deviations (gaps), resolves them correctly and preventively.
- Takes the initiative to solve problems, where possible yourself and otherwise in close cooperation with the Manufacturing Supervisor and/or manufacturing specialist/process engineer.
- Replaces the Manufacturing Supervisor in the absence of process related tasks.
- Responsible for preparing the training schedule and ensuring that appropriate training is given to manufacturing operators in existing and new processes and technologies.
· Responsible for continuous improvement of work processes and procedures.
With your specific drug product knowledge you will contributing to continuous improvements of work processes and procedures and participating in projects.
- Signals structural shortcomings and opportunities for improvement. You are involved or coordinate improvement initiatives (CI) that are practical in nature and do not require support from other departments.
- You are responsible for (co-)developing work processes and procedures in consultation with manufacturing specialists/process engineers.
- Proactive role in department improvement initiatives (BI/CI improvements) and participates in the initiation phase of QIs and is involved in deviation investigation and follow up.
· Participation in Projects
- Contributes information and ideas in departmental and project meetings.
- Is a project team member and/or is consulted by team members to realize project goals.
- Support implementation of new equipment, process, and procedures
- During the preparation phase (the transfer of new products to the VLF per 2024), you will be contributing to the realization of the production possibilities in our factory the coming years.
If you meet the following Job requirements, we would like to hear from YOU:
You have an education on MBO level 4 and Experience of 2 - 4 years in a BSL2 environment, with expertise in Drug product, virus propagation, GMP and EHS standards.
Good communication skills in English and Dutch, both verbally and in writing.
We prefer a degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education) and a certified Lean (Yellow or Green) Belt.
Preferred key competencies:
· Quality oriented and precise: Likes to perform according to work instructions with the highest level of safety, compliance and quality.
· Analytical thinking: ability and dealing with complexity, asking questions, using data and information.
· Improvement mentality and a “Can do” attitude: Supports a progressive learning culture by encouraging and helping others to recognize and implement improvements and changes.
· Collaboration: Is open to the opinions and ideas of others in the team. Actively listens to different points of view, perspectives, opinions, backgrounds, and preferences in order to propose solutions.
Clearly shows that the joint result is important and seeks collaboration based on the idea that collaboration leads to better performance for the company.
· Stress-resistant: continues to work calmly and effectively in the event of deadlines, serious disruptions, insufficient resources, and setbacks. Does not compromise on the quality of own work, even when the pressure to do so is great.
This is what awaits YOU at J&J:
· An opportunity to be part of a global market leader, with a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments.
· A dynamic and inspiring working environment with career opportunities and continuous personal and professional development in areas of technology and leadership.
· Personal Development Plan – such as access to further education & training, Insights Discovery training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
· Many employees benefits like:
- Flexible working arrangements with J&J Flex, enabling you to work from home;
- provides a middle wage pension plan . It is company sponsored with an employee contribution of 4%.
- 36 days holidays (based on full-time employment);
- a monthly allowance of 20 EUR for a subscription to a sport center and a bike plan.
- Global Parenteral Leave policy offering 12 weeks of leave (birth/parenteral, adoption/foster care and parenteral) at 100% pay to parents.
Our Commitment to 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”!