Johnson & Johnson / Viral Launch Facility IS looking for a
Senior process engineer, building our drug product capability
At the Janssen Pharmaceutical Companies of Johnson & Johnson , 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 products for patients around the globe. One of the key focus area’s for Janssen in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.
At the Janssen site in Leiden (located at the Bioscience Park), we work with more than 2100 dedicated and multi-skilled people in 5 different business units. We produce different product and pioneer solutions to deliver better health. This vacancy is for Business Unit 2: The Viral Launch Facility (VLF).
The VLF is Janssen’s state-of-the-art GMP manufacturing facility from which we launch and grow new and innovative Gene Therapeutic 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.
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 the Drug Product process.
The PTP team consists of 12 professionals with in-depth knowledge of specific subjects such as Upstream processing, Downstream processing, Project management, process excellence and safety. Together, we make sure to have safe, lean, robust, manufacturable, and compliant processes.
The process engineers in the team are process owners and have two major roles:
- Ensure that new processes and enabling technologies are smoothly implemented into the VLF, using solid project management tools and extensive (bio)technical knowledge. PTP employees are key members or leads during Technology Transfers, New Product Introduction and in projects involving process changes.
- Support existing processes and technologies by investigating and assessing major process deviations, identifying and implementing process improvements, and analyzing critical process data. During the launch, grow and commercial phases the PTP process engineers are process owners and subject matter experts (SMEs) on the previously introduced processes.
Close collaboration with the other VLF departments is vital to ensure that the overall VLF goals can be achieved. The other two departments in the VLF are:
- The Operations Department 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 VLF are operational, safe, compliant, robust and ready for the future.
Responsibilities and the impact YOU will have:
This vacancy is for a Subject Matter Expert (SME) on the Drug Product process (fill & finish). You have different roles (Process owner NPI, base business supporter and project member or – lead) and responsibilities:
As a Process owner NPI, you:
- ensure 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 VLF for the robust and compliant implementation of a manufacturable process are defined precisely.
- work closely within the Technical Transfer team to ensure that the (development) knowledge is accurately transferred into the process and operational documentation. In addition, you will collaborate with PTP members in other expertise areas, the manufacturing specialists (system owners), operators and GMP specialists.
- will be the interface and do stakeholder management with MAKE Asset Management (MAM), clinical, regulatory and quality departments, the Value Chain team and VLF management team.
- will be single point of contact (SPOC) for the site tender team for drug product processes in the VLF.
- Support production of cGMP batches for exiting processes in the VLF in the area of drug product.
- 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.
- have the overview and knowledge of the status of the process, including ensuring stability of critical parameters, ongoing investigations, registered process and analysis of ongoing process data.
- 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.
- Lead or are key member in projects involving process changes and implementation of (enabling) technologies, including Digital Technologies.
- Are the interface with the product owners (MSAT or R&D), regulatory and value chain departments and work with MAKE Asset Management (MAM).
If you meet the following Job requirements, we would like to hear from YOU:
- Bachelor / master’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.
- In depth, up-to-date knowledge of Drug Product Processess.
- Excellent communication in English, verbally and in writing.
- You are proven resilient. You can deal with challenges, changes and unexpected setbacks in a positive and meaningful way.
Preferred knowledge and experience :
- Project management skills.
- Certified (Lean) Green Belt
- Good understanding of regulatory requirements and industry guidelines specific for the pharmaceutical manufacturing industry (e.g. GMP, Annex 1, etc.).
- Good communication in Dutch, verbally and in writing.
Preferred key competencies:
- Collaboration: Is assertive or adaptable at the right times and to the right degree. Actively looks for feedback and provides team members with meaningful feedback and coaching. Celebrates successes and embraces failures together. Actively connects with peers/colleagues/stakeholders/external partners and makes use of these connections within the organization.
- Analytical thinking: Successful in identifying, determining, and solving problems. Identifies areas for improvement having high impact and proposes a solution.
- Communication: Good communication and alignment on issue or change management. Stimulates open communication and can adapt communication style to the situation.
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.