Deskripsi
Are you passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today! CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium) and new build Lab’s and warehouse will be operated from the existing Janssen Beerse site. We are establishing the Engineering & Technical Services organization which will provide ownership and oversight for the entire asset portfolio and associated business processes for Janssen’s Advanced Therapies Supply Chain globally.
This role provides technical expertise, leverages best practices, and develops internal as well as external partnerships around our ISA-95 level 1 and 2 (manufacturing) automated systems and applicable interfaces serving the Beerse and Ghent sites. It will ensure that automated systems are fit for intended use and follow applicable regulatory requirements and company manufacturing standards throughout the entire system life cycle and ensure flawless liaison with the different teams, vendors, sites, and stakeholders. The role holder is a specialist in the field of industrial automation with extensive experience of systems and platforms across this sector. S/he feels naturally comfortable with the accountability of maintaining and enhancing these systems as well as identifying and driving opportunities for continuous improvement across the systems and platforms. The ideal candidate possesses a strong track record in Industrial IT Systems/Automation, proactive communication, and a willingness to be hands-on in technical tasks.
Tasks and Responsibilities :
- Maintain and keep the industrial IT systems (e.g. BMS, EMS, IDP etc.) in a compliant state with its procedures, work instructions and all applicable regulatory GxP and corporate requirements throughout the entire system life cycle.
- Ensure reliable availability of the systems, including the containing data.
- Act in a troubleshooting role to find root cause and propose a solution (potentially 24/7 on-call support is required).
- Configure and manage system interfaces, conduct system performance monitoring, implement & maintain network configuration (in partnership with IT); provide training to end users and system admins; lead and supervise modifications/projects implementation, create and maintain lifecycle
documentation
- Ensure that the user requirement specifications and all applicable objectives are met to maintain the platform daily (including back up, disaster recovery, user administration etc.)
- Lead vendors, subcontractors and/or technical integrators.
- Review, develop and execute (commissioning) protocols, test plans, reports, and documentation to implement, maintain, operate and validate cG(x)P automated systems.
- Drive innovation and new technologies.
- Supports investigations, deviations, corrective and preventive actions towards successful timely and compliant closure
- Actively communicates regularly with project leads and project delivery stakeholders
Kualifikasi
- A technical education / degree in industrial automation or relevant engineering discipline is required, at Bachelor level or higher
- Experience in a GxP regulated environment with a required minimum of 4-6 years and proven knowledge of current Good Automated Manufacturing Practices (GAMP).
- Experience in industrial automation technology standards and validation in Pharma industry is preferred.
- Good organizational skills, including experience organizing self, coordinating, and initiating work arrangements with minimal direction and the capacity to work under stress.
- Previous experience working in a large matrix-managed environment preferred
- Fluent in English (written and spoken), Dutch language at level C1 preferred
- Proactive, open team player with a service mindset
- Working regimen is approx. 60% Ghent, 30% Beerse, 10% travels