Biotech and Agricultural Engineering Medical and Healthcare Other Science and Tech
1 - 2 Years
GMP Specialist - Deviation Lead
Location: Leiden, Netherlands
Contract: Full Time/Contract
Department: Centre of Expertise – COVID 19 Vaccine Team (CV19)
Janssen Vaccines & Prevention are currently recruiting a GMP Specialist/Associate GMP Specialist within our Vaccine Launch Facility, Centre of Expertise to strengthen our team responsible for the ground-breaking development of the COVID 19 Vaccine. The successful candidate will have a background in the biologics/pharmaceutical/manufacturing industry as well as a bachelor’s qualification in a relevant area.
About the Company:
Janssen Vaccine Launch Facility (VLF), 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 Centre of Expertise is a team of 15 which play a central role within the VLF, divided in three expertise: 1) GMP specialism, 2) Single use technology and 3) Manufacturing systems specialisms. This team is responsible for batch continuation by troubleshoot & support in production, robust and availability of process equipment, and control and change management of GMP processes.
The responsibilities & the impact YOU will have:
As GMP specialist - Deviation Lead, you will support the operations teams in general cGMP and EHS related tasks (changes, quality issues, training, GMP and EHS documentation and reports).
In particular, as Deviation Lead, you will be responsible for the progress and well-structured approach of quality issues. You will be the coordinator and facilitator of QI meetings and (technical) investigations. You are critical on GMP, and care for preventative solutions with keeping a workable procedure for operators. You are supportive to the operations department, the equipment owners and the process engineers, to collaborate in team for each quality issue.
As GMP deviation lead, you work closely with your Center of Expertise colleagues and the VLF staff engineers and with the all the other teams of the VLF. As well as GMP Training, Document control department, QA department, and Compliance department.
As GMP specialist - deviation lead, you will be responsible for:
Keeping general VLF GMP documentation up-to-date.
Improving on production processes and systems within the VLF.
Improvements regarding relevant EHSS standards applicable to the VLF (including support in on-going EHSS investigations.
Writing change controls for the GMP/ EHS systems and VLF improvements, and responsible for follow up and timely documentation and completion.
Support/lead deviation investigation in documenting product impact analysis and root cause investigation and timely follow up (including CPA records) and completion.
Training coordination and responsible for the training-syllabi within the VLF.
Coordination of documentation periodic review within the VLF.
Working precisely, detecting and solving acute problems and communicate possible abnormalities.
Leading process excellence activities to continuously improve the work as well as personal skills.
Note: In general, the associate role will have ownership on less complex GMP roles and supports the GMP specialists in complex issues or priority projects.
We would love to hear from YOU, if you have the following essential requirements:
Bachelor degree in Biotechnology, Biochemistry, Biomedicine, Process Technology (or equivalent education).
2-8 years’ experience in a biotechnology or biopharmaceutical industry environment. (years of experience will determine whether you will be placed in an associate GMP role or at a higher level)
Experience with cGMP and EHSS standards is required.
Demonstrated GMP and EHSS awareness.
Experience in Root cause analysis, product impact assessments, CAPA definition
Experience with Trackwise QEM, Docspace and CURVE is preferred
General knowledge in cell culture (USP), bioreactors, virus propagation and/or downstream processing (DSP).
Enthusiastic Team player, flexible, “Can do” attitude, critical and proactive.
Good 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
Flexible, can deal with changing priorities
This is what awaits YOU at J&J:
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:
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
Netherlands-South Holland-Leiden-Einsteinweg 101 Organization
Janssen Biologics (7266) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies