MATERIAL READINESS ENGINEER

At the Johnson & Johnson Innovative Medicine, 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 JNJ in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.
At the JNJ site in Leiden (located at the Bioscience Park), we work with more than talented and multi-skilled people in 5 different business units.
We produce different products and pioneer solutions to deliver better health.
This vacancy is for Business Unit 2.
The Gene Therapy Facility (GTF).
The GTF is JNJ’s state-of-the-art GMP manufacturing facility from which we launch and grow new and innovative Gene Therapy products.
The facility has two manufacturing suites.
In suite 1 we produce Drug Substance (e.
.
cell & virus cultivation and purification processes).
In suite 2 we produce Drug Product (e.
.
Fill & Finish processes) for the final product.
Both production suites in the GTF are in the final stage of preparation for Phase 3 and commercial production to accommodate the transfer of new products to the GTF per .
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 Process, Technology and Projects (PTP) team and strengthen our department with knowledge and expertise of material supply and material readiness.
The PTP team consists of 12 professionals with in-depth knowledge of specific subjects such as Upstream processing, Downstream processing, Drug Product, Project management, process excellence and safety.
Together, we make sure to have safe, lean, robust, manufacturable, and compliant processes.
You will contribute to the technology transfer from R&D to manufacturing as lead of the material readiness team.
This includes designing materials, ordering materials, make sure materials are safe, materials are released on time and available in right GMP status for production.
Close collaboration within and outside GTF is vital to ensure that the overall GTF goals can be achieved.
Within GTF you will work with.
The Operations Department, that is responsible for timely, compliant, safe and first-time right manufacturing and delivery of the planned batches The system owners in the Center of Expertise (CoE) ensure that our production equipment and single use flow paths in the GTF are operational, safe, compliant, robust and ready for the future.
You will work especially close with the single use experts.
The process owners in the Process Technology and Projects team The departments you work closely with outside GTF are global planning, procurement, material sciences.
Responsibilities and the impact YOU will have.
This vacancy is for a Material readiness engineer.
You will.
Lead the core team that is responsible for material readiness.
Be team member of the new product introduction team, reporting to the technical launch integrator.
Make sure that all single use items and raw materials are delivered in time for the first batches.
Connect the different stakeholders and departments that need to deliver input and output.
Ensure that the ordering process runs smoothly, and bottlenecks are addressed.
Ensure that GMP material qualification according to J&J procedures is performed on time.
Additional responsibilities can include.
Supporting Single Use Subject Matter Experts Facilitation of implementation of lean production and work processes.
Project and program management tasks Technology transfer, ensuring that the implemented process is well defined and aligned with the operational procedures.
For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the GTF for the robust and compliant implementation of a manufacturable process are defined precisely Support production of batches in the GTF.
Initiate and handle compliance records (change control, CAPA, deviations), including investigation of major deviations for potential product impact, root cause investigations of complex deviations, evaluation of changes prior to implementation and data gathered post implementation to prove that the change had the desired effect.
Identify and conceptualize (process) improvements to increase the speed, reliability, yield or capacity of the process, define scope and deliverables, lead or be member in a team to implement agreed change and realize the agreed goal.
Qualifications If you meet the following Job requirements, we would like to hear from YOU.
Qualifications.
Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education or experience).
Proven experience in a biotechnology or biopharmaceutical industry environment, in a cGMP environment and with EHSS standards.
Proven knowledge in at least one of the following aspects.
Processing in Single Use assemblies, Upstream processing (cell or virus cultivation), Downstream processing (TFF, chromatography, DS fill) or Drug Product processing (Filling, Visual Inspection).
Excellent communication in English, verbally and in writing.
Established project management skills.
You are proven resilient.
You can deal with challenges, changes and unexpected setbacks in a positive and meaningful way.
Preferred knowledge and experience.
Certified (Lean) Green Belt Good understanding of regulatory requirements and industry guidelines.
Good communication in Dutch, verbally and in writing.
Preferred key competencies.
Decisive, pragmatic and persevering with a can-do mentality.
Stimulates open communication and can adapt communication style to the situation.
Recognizes, acknowledges, and involves employees with different backgrounds, talents, knowledge and ideas.
Can deal with uncertainties, escalates clearly and timely.
Can absorb complex information and is analytical.
successfully recognizes and solves problems by actively gathering information, analyzing, and connecting multiple signals and sources and discovering the root cause/suggesting a solution to the problem.
Ability to create a path forward even if the solution is not yet clear or there is no standard process.
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”!