Location: Leiden, Netherlands
Department: Process Excellence – COVID 19 Vaccine Team (CV19)
Janssen Biologics are currently recruiting Process Improvement Engineers within our Process Excellence team to support the groundbreaking development of the COVID 19 Vaccine. The successful candidate will have a background in the pharmaceutical industry as well as a bachelor’s qualification in a relevant area.About the Company:
Janssen Vaccine Launch Facility (VLF) within Janssen Biologics, part of the Johnson & Johnson Family of Companies, is a state-of-the-art vaccine manufacturing facility at the Bioscience park in Leiden, where we proudly produce leading medicines against diseases that have a global impact, such as vaccines against HIV and RSV. Development of the COVID-19 vaccine is also underway, in-house, through Janssen Vaccines and Prevention. This is part of the Johnson and Johnson Credo of putting patients and healthcare professionals first. The responsibilities & the impact YOU will have:
The VLF is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes. Within this facility, the Process Improvement Engineer is the key person to provide leadership and support for a cGMP compliant and a lean sustainable work environment. You will work closely with the process engineers, equipment owners and the production teams for GMP and PE related support and you will form a team with the other quality engineers sharing knowledge and responsibilities.
You will also take ownership of the following:
- Ensuring our operations and processes are running within the desired cGMP compliance regulations of the Pharmaceutical and Johnson & Johnson standards and guidelines in an effective way.
- You will be the point of contact within the Launch Facility for questions related to cGMP (training, inspections, audits, deviations, reports and documentation).
- System ownership of general production processes like gowning, routing, flow, and segregation.
- The implementation of our business processes on departmental level - You will shape and maintain a PE/lean culture by continuous improvements, problem solving (Gemba, kaizen facilitator, A3, etc..)
- Leading and supporting the Quality and GMP related aspects of the Launch facility activities, which will assure that our operations and processes are running within the desired compliance regulations in an effective way.
- Ensuring the inspection readiness of the launch facility and performing self inspections.
- Function as point of contact during inspections and follow up.
- Lead and support all Process Excellence related processes and projects which will further embed and improve the lean culture and analytical troubleshooting capabilities of the organization.
- Initiate and handle compliance records (CC, QRA, nonconformance’s and CAPA records) including root cause analysis.
- Function as training coordinator within the launch facility.
- Act as departmental contact for questions about cGMP systems.
- Support and advise on GMP aspects usage in maintenance and project execution.
- Provide complex team support to all sub-groups within the launch facility in optimizing and aligning their internal processes and communication (e.g. Manufacturing Equipment Excellence (ME2) methodology).
- Utilize multifaceted industry and process excellence methodologies on an expert level (e.g. 6-sigma, greenbelt methodologies).
We would love to hear from YOU, if you have the following essential requirements:
This is what awaits YOU at J&J:
- WO Bachelor’s degree in preferably in one of the following disciplines: Biotechnology, Process technology Mechanical engineering, or equivalent
- 3-6 years’ experience in a biopharmaceutical (GMP) production environment. (pay grade will depend on level of experience)
- Certification (YB/GB level) in at least one of the CI methodologies is required
- Expert in cGMP environment, knowledge of regulatory requirements and global standards is required.
- In depth knowledge of cell culture (USP), bioreactors, virus propagation and downstream processing (DSP).
- Strong communicator and team player, good in building relations with variety of people and departments.
- Open for continuous improvement and development of organization, processes and people.
- Trainer skills are a desirable requirement
- Agile ability to be a process excellence change agent capable of influencing without direct authority
- Interest, energy and motivation to work in a fast-moving vaccine environment
- Experience of working within a team
- Excellent communication skills in both English and Dutch
This is an opportunity to work with a ground-breaking vaccine development team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the ~1000 people who work here, or you’re considering joining the team, we offer:
- Flexible working hours
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Opportunities to work on challenging projects and assignments
- Possibilities for further personal and professional development/education
- Excellent Benefits
Janssen Biologics (7266)Job Function