At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease! Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
MAKE Asset Management (MAM) organization:
The MAM organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems activities. This occurs in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing & Technical Organization (MTO) and in conjunction with key partners, to create one integrated internal/external network.
Janssen Supply Chain (JSC) is recruiting for an Engineer, Execution Systems, Site Beerse. The Engineer will report to the Execution Systems site lead.
The site ES engineer will be responsible for implementing, supporting and maintaining the ISA-95 level 1, 2 and 3 systems. Site ES engineer will execute all the activities required to ensure that computerized systems are fit for intended use and compliant with applicable regulations throughout the entire system life cycle
Site ES engineer will be responsible to maintain and update local recipe element (process content, technology process actions and phases, libraries).
- Project leadership of ES projects, including obtaining agreement on project definitions and priorities and ensuring that resources, capabilities and processes are in place.
- Acts as project leader/core team members by tracking cost, quality and schedule ensuring an effective management of project execution
- Ensures programs stay on plan by resolving resource conflicts and removing obstacles, which may involve negotiations at a senior level within the business and Execution Systems COE.
- Establishes effective working relationships with Quality, IT, Lab Systems, Procurement, PDMS departments and others as well as develops new partnerships to optimize processes.
- Ensures sound technical engineering concepts are applied in all tasks.
- Develop a mechanism to proactively assess business needs and to identify points of leverage across functional groups in the Small Molecule Platform.
- The position is responsible for the following tasks
- Create Master Recipe within the Control System and/ or MES
- Support Execution Systems related (legacy) systems
- Configure and manage system interfaces
- Conduct local ES system data performance monitoring
- Ensure site compliance and adherence with global/ platform standards
- Feedback site needs and priorities to Global enterprise through Platform governance
- Write and execute validation protocol - CSV
- 24/7 system support (local execution, with option to elevate to Global platform level)
- Execute against global SOPs (including back up, disaster recovery, user administration etc.) and manage site specific work instructions
- Participate in compliance inspections for topics related to ES systems
- Implement & maintain network configuration (in partnership with IT)
- Providing (User) training to end users and system admins
- Provide user defined reports and facilitate ad-hoc queries
- Conduct Integration testing (IQ) and Functional testing (OQ)
- Hold risk assessments
- Manage and execute ES related projects
- Create and maintain lifecycle documentation management for applications
- Create Functional Specification and Design Specification
- Conduct module testing, Functional Acceptance Test (FAT) and Site Acceptance Test (SAT)
- Support and participate in investigations (Events/CAPA's) for deviations related to ES systems
- Collaboration and partnership with the various internal and external partners like Quality, IT, Lab Systems, Technical Operations, PDMS, Production and others as well as collaboration with General Managers
- Ensure compliance in all aspects of Environmental, Health, Safety and Sustainability (EHSS) per Johnson & Johnson standards.
- A technical education / degree in industrial automation, information technology or relevant engineering discipline is required.
- 2 - 5 years of experience is preferred, however this role is open to recent graduates
- Experience within a GMP-regulated environment is preferred
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.
We are an equal opportunities employer.
Live Our Credo & Pursue Our Purpose:
As part of the Johnson & Johnson family of companies, Our Purpose is ‘We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.’ We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.
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 create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.