Deskripsi
Execution Systems / Pollux Automation Engineer (M/F/X)
Project Pollux is the establishment of a new Janssen Supply Chain Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands to be organized as a new business unit for Janssen Biologics (JBV). This biologics manufacturing facility is intended to become a key supply option for commercial LVV in support of the global Janssen BCMA CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually.
The Pollux production facility is currently under initial design development, with the following milestones in the long-lead project plan:
- Completion of preliminary engineering (Basis of Design)
- Completion of full (detailed) design
- Facility construction and building commissioning
- Facility and production equipment qualification
- Producing validation batches, site approval, start routine production.
For this project Janssen Biologics is recruiting an Industrial Automation Regular Engineer to work within the Execution Systems department to support this new facility now and in the future.
Job Summary:
MAM - Execution Systems (ES) is a dedicated team of enthusiastic and skilled Automation professionals with various technical expertise, responsible for the (support of) implementation, validation, qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the Leiden manufacturing facility. We ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.
The Execution Systems Engineer is experienced in the field of industrial automation and experienced with systems across this sector. The ES Engineer feels naturally comfortable with the responsibility of maintaining and enhancing their systems as well as supporting continuous improvement across their systems and platforms.
In this role you will first act as a Technical System Owner designee and work with a dedicated team that is focused on design, implementing and commissioning of Building / Environmental Monitoring and Pharmaceutical of the shelf automated skids. During the project you always think about the maintainability, sustainability, and step up when this is in jeopardy during the project phase. Together with project members and system owners you arrange the needed automation support for after the project. The second phase of this role will be after the project were you and your ES Base Business colleagues support and maintain the Pollux facility.
The responsibilities and the impact YOU will have:
During the Pollux project phase you collaborate with Users, HVAC/PLC Engineers, System owners and operators
- After the project you work together with system owners to Maintain and keep the automation platforms in a compliant state with its procedures, work instructions and all applicable regulatory GxP requirements throughout the entire system life cycle.
- Ensure reliable availability of the automation systems, inclusive the containing data.
- Act in a troubleshooting role to find root cause and propose a solution (potentially 24/7 on-call support is required).
- Craft, lead technical strategic plans.
- Contribute to the needed budget requests for OPEX and CAPEX expenses to local and global management.
- Lead and supervise modifications and or projects.
- Ensure that the user requirement specifications and all applicable objectives are met to maintain the platform daily.
- 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.
Kualifikasi
We would love to hear from YOU, if you have the following essential requirements:
Capabilities identified as priority for our Workforce of the Future are:
- Digital & Technology
- Change Leadership
- Critical Thinking & Problem Solving
- Process knowledge & expertise
- End to End mindset
Qualifications:
- 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 2-6 years and proven knowledge of current Good Automated Manufacturing Practices (GAMP).
- Experience in industrial automation technology standards and validation in Pharma industry is preferred.
- Proven knowledge in Building Automation (Honeywell) and PLC programming structures
- Preferred knowledge in Priva (Building Automation), Siemens S7 & Tia Portal (PLC), ArchestrA (SCADA), OsiSoft (PIMS), SynTQ (Process Analytical Technology) and GxP infrastructure
Key Competencies:
- Good organizational skills, including experience organizing self, coordinating, and initiating work arrangements with minimal direction and the capacity to work under stress.
- Demonstrated medium level communication skills and excellent interpersonal and relationship building skills in all layers of the organization including the ability to work independently, flexibly, and collaboratively, and to negotiate effective business outcomes. English and Dutch required, but only one language fluently.
- Decisive, pragmatic and persevering with a can-do mentality.
- Process Automation insights, and always looking for the organizational process behind events.
- Ability to understand relationships and different interests in a sophisticated organization.
- 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.
- A dynamic and inspiring working environment.
- Career opportunities and continuous personal and professional development in areas of technology and leadership.
- Personal Development Plan – such as access to further education & training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
- Be part of a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments.
- Many employee benefits like:
- Flexible working arrangements with J&J Flex, enabling you to work from home
- 36 holidays. Based on full-time employment and 20 statutory holidays + 16 non-statutory holidays.
- Global Parenteral Leave policy offering 12 weeks of leave (birth/parenteral, adoption/foster care and parenteral) at 100% pay to parents.
- and more