Johnson & Johnson Careers
Lead engineer SUT en GMP
Requisition ID: 1905761051W
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Operations Team in the Launch Facility we are looking for an enthusiastic and talented
The Vaccine Launch Facility (VLF) is a state-of-the-art vaccines manufacturing facility which is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes.
The Operations Department plays a central role within the VLF and is responsible for on time delivery of the planned batches against the high-quality standards and safety and compliance regulations that are applicable for Vaccine manufacturing.
The Operations Department holds around 50 people and is divided in 4 teams. 3 Teams are responsible for the actual on time production and delivery of the batches (USP, DSP and Operations Support) and 1 Team (COE) is responsible to support the production teams with specialized and in-depth knowledge and skills on our production processes. The Centre of Expertise (COE) is a team of around 10 people. We are currently recruiting to extend our group with a Lead Engineer Single Use Technology and GMP, to provide the VLF in all GMP related items and to bring the Single use Technologies standards to the next level.
As Lead Engineer Single Use Technology and GMP, you will have two main responsibilities in the Centre of Expertise of the VLF. Watch over and lead the operations teams in general cGMP related tasks (changes, quality issues, training, GMP documentation and reports), including the support of a safe, healthy and sustainable work environment.
Secondly. you will own the procedures and lead the processes around single use technologies. This includes the introduction of new single use technologies, timely delivery of all assemblies, inventory management, documentation of procedures and instructions of single use technologies and customer complaints.
As Lead Engineer Single Use Technology and GMP , you work closely with your Center of Expertise colleagues, the VLF staff engineers and with the all the other teams of the VLF.
As Lead Engineer Single Use Technology and GMP, you will be responsible for:
- The GMP status of all VLF procedures and documentation.
- Act as project lead for major improvements and deviations.
Guide the improvements on production processes and systems within the VLF.
Lead high impact deviation investigation in documenting product impact analysis and root cause investigation and timely follow up (including CPA records) and completion.
Be the first contact person for Single-Use-Technologies and GMP procedures during (internal/external) inspections
Build and invest in relationships with the supplier of the Single-Use-Technologies.
BSc or MSc degree in biotechnology, biochemistry, biomedicine, process technology or equivalent.
- Min. 4 years’(MSc) or 6 years’(BSc) experience in a biotechnology or biopharmaceutical industry environment.
- Experience with cGMP and safety standards is required.
- Experience with Trackwise QEM and Docspace is required.
Demonstrated insight in conceptual thinking and practical technical perspective.
Experience with Lean methodology, Certified Green Belt is preferred.
- Experience in single‐use technology is preferred.
- Enthusiastic Team player, flexible, “Can do” attitude, critical and proactive.
- Excellent communication in Dutch and English, both verbally and in writing.
- High degree of accuracy, initiative, and independence.
- Innovative: Continuous innovation of the work processes and working environment.
- Analytical ability and dealing with complexity.
- Strategic thinking: setting frameworks and goals and translating the departmental vision from the Business Cascade.
- Collaboration and communication: Build solid, productive relationships
- Decision making: Can make timely decisions within set frameworks.
For more information about this position please contact L. Van der Vlist via 06-15668204 / +31 71 305 3514 / email@example.com.
If you are interested in this new challenge?
Please apply directly online via Mycareeropportunities (MCO). (vacancy number: 1905761051W)
Janssen Biologics (7266)