Vacature Manufacturing Specialist

Supply Chain Manufacturing

Manufacturing Specialist GTF DP

• Titel Manufacturing Specialist GTF DP
• Functie Supply Chain Manufacturing
• Sub functie Manufacturing Pharmaceutical Process Operations
• Categorie Lead Technician, Manufacturing Pharmaceutical Process Operations (S4)
• Locatie Leiden, South Holland, Netherlands
• Referentie 24W

Beschrijving

At the Johnson & Johnson Innovative Medicine, we are working to create a world without diseases. Redefining lives by finding new and improved 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 2400 dedicated and multi-skilled people in 5 different business units. We produce different products and pioneer solutions to deliver improved 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.g. cell & virus cultivation and purification processes). In suite 2 we produce Drug Product (e.g. 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 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!

We are looking for a Manufacturing Specialist who will strengthen our department with knowledge and expertise of the Filling process and equipment according to Annex 1.

You will become part of the Centre of Expertise (CoE) team. The CoE team consists of 12 highly skilled professionals (Manufacturing specialists on Drug Substance, Drug Product and Single Use). CoE ensures that our production equipment and single use flow paths in the GTF are operational, safe, GMP compliant, robust and ready for the future.

As system owners we enable operations to process first time right with our equipment and guidance. This is varying from initial training, writing procedures and instructions till working together in project teams. We enable Operations to excel in production reliability.

During the project phase you will work on the technology transfer from R&D to manufacturing. You will participate in manufacturing readiness initiatives of new equipment and processes. This includes process documentation, training of operations, and qualification of the systems and processes.

As soon as the facility is in operation you will further develop the manufacturing process to achieve a stable and reliable operation. In your role as system owner, you are the first responsible person to perform acute troubleshooting and support of cGMP batches in the GTF.

Besides this you will be playing a key role in the further development of the Business Unit in terms of new product introduction, efficiency, and reliability.

Responsibilities and the impact YOU will have:
As a Manufacturing Specialist Drug Product you will be a system & equipment owner, troubleshooter, and project member or - lead:

As Manufacturing Specialist you:
Manage and use the business processes, with which the equipment performance is analyzed and makes proposals for improvement points with the greatest impact on a specific objective (safety, quality, reliability/efficiency and costs).
Identify, plan and control changes for system and process robustness (team task allocation and prioritization 0-3 months timeframe);
Lead/owner business processes and projects that are mainly system or facility related, with peers in service oriented or operating departments.
As system / equipment owner you:
Assuring production equipment is in validated state, documentation is up to date, well maintained, and production capacity meets planning.
will play a key role in the interaction between our Operation Department on one site and the Maintenance and Engineering teams on the other site.
generate the process equipment related reports and KPI's. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity).
initiate and complete test protocols that help to improve the system or process.
As troubleshooter you:
are the first responsible person to perform acute troubleshooting and support of cGMP batches regarding the Drug Product processes in the GTF (fill of the product in vials).
detect (Gemba walk) and solve acute problems and communicate possible abnormalities.
As project member/lead you:
be involved by acquiring and introducing new equipment for the manufacturing of new types of products.
participate in root cause investigations of sophisticated deviations and for the implementation of preventive actions.
participate in handling of compliance records (change control, events, CAPA, deviations).
lead process excellence activities to continuously improve the work as well as personal skills.

Kwalificaties

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).
• 8-15 years' experience in a biotechnology or biopharmaceutical industry environment. Minimal 6 years for WO graduate
• Shown knowledge in at least one of the following aspects: Annex 1, Drug Product Filling, Visual Inspection.
• Proactively sees and finds work, knowing and visibly taking ownership of responsibilities.
• Excellent communication skills, written and verbal in English.

Preferred knowledge and experience:

• Preferred knowledge/ In depth, up-to-date knowledge of DP labelling,
• Experience in a GMP regulated environment and proven knowledge off Single Use systems.

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.
• Dares to say no, 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 35 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.

By joining Johnson&Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world's healthiest workforce you can strengthen your body as well as your mind. When you work at Johnson&Johnson you can touch over a Billion of lives worldwide every day. And when you apply your talent to our collective purpose there's no end to the lasting impact we can make together. And that changes everything.

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"!

Are YOU interested?

If you are interested in this position and you are the enthusiastic Manufacturing Specialist DP who enjoys implementing and making a new filling process operational, respond to this position. For questions about this position, please contact Laurens van der Vlist (0031-6-1566 8204).

Functie:	manufacturing specialist
Startdatum:	30-04-2024
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Johnson & Johnson via onbekend of onbekend. Of bezoek hun website onbekend.