The world of Automation Systems is a constantly changing and evolving world. Each day new technologies and continuous improvements arise, creating new opportunities. These new opportunities can lead to improvements on safety, product quality, cost, efficiency and thus indirectly improving the life of our J&J colleagues and patients worldwide.
Before these benefits are gained, a lot of effort is required to implement and finetune these systems. Requiring a strong cooperation of operations, technical departments, IT, QA, vendors... Requiring a strong team managing and owning these executing systems.
The Execution Systems Engineer will report to the Execution Systems lead.
The Execution Systems Engineer key accountabilities are as follows:
- responsible for implementing, supporting and maintaining the ISA-95 level 1, 2 and 3 systems.
- 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
- to maintain and update recipe element (process content, technology process actions and phases, libraries)
- contribution to the development of business and/or functional strategies and capabilities related to ES.
- contribution to data analytics and digitalization within Asset Management (MAM)
- establish ES related system roadmaps and delivery of same.
- execution of ES standards and delivery of business results
- Partner with JJT, MAM CoE, SCSS, other CoE’s or functions to deliver the above, utilizing an integrated ES approach.
The position is responsible for the following specific tasks:
- Create Recipe within the Control System
- Support Execution Systems related (legacy) systems
- Configure and manage system interfaces for L1, L2 & L3 systems
- Govern the ES system administration activities
- Ensure site compliance and adherence with global/cluster standards
- Feedback site needs and priorities to MAM CoE / Global enterprise through platform governance
- Write and execute validation protocol - CSV
- 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 JJT)
- 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
- Responsible for Implementation, Deployment & Support of ES related standards and tools
- User Requirements Specification
- Execute ES related vendor contracts
- Manage design of business processes and technology application according to S95 standard and system boundaries in alignment with E2E business design
- Share best practices (e.g. project mgt. tools, system adoption, training tools and content, programming/ documentation standards, MBR modeling)
- Assess, design and implement Manufacturing for the Future (MFF – Industry 4.0) type new technologies i.e. the creation of contextualized data and the identification and implementation of data analytics tools.
- Acts as project leader/core team members by tracking cost, quality and schedule ensuring an effective management of project execution
- Establishes effective working relationships with Operations, Quality, JJT, MAM COE, SCSS, One Lab Systems, Procurement, TO, DPDS departments and others as well as develops new partnerships to optimize processes.
- Ensures sound technical engineering concepts are applied in all tasks.
- Capable of working in a matrix organization for engineers at site or platform level.
- Ensure compliance in all aspects of Environmental, Health, Safety and Sustainability (EHSS) per Johnson & Johnson standards.
- A technical degree in industrial automation, information technology or relevant engineering discipline is required.
- A minimum of a Bachelor's degree in Engineering
- Experience in GMP or GLP regulated environment and a related position is required.
- Experience delivering innovative technical and engineering solutions in multiple manufacturing environments is required.
- Knowledge of Process Excellence tools (Lean, Six Sigma) preferred. Green or Black Belt Certification in Lean or Six Sigma is preferred.
- Knowledge of technology development and validation, including design of experiments and statistical analysis, is preferred.
- Knowledge of Data Integrity guidelines
- Must have the ability to assess and mitigate technical risks.
- Project leadership experience is preferred (FXP Project Lead Certification is preferred)
- Familiarity with IT application design and deployment is required.
- Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
- Excellent verbal and written communications skills
- Strong decision making and problem-solving skills
- Must have the ability to think strategically and manage change.
- The ability to collaborate effectively with all levels of management and drive alignment in a global environment is required.
- must demonstrate strong cross-functional business acumen, as well as the experience in information technology deployment
- Experience in managing multiple stakeholder groups
- Data Integrity and
- Technical knowledge on ISA-95 L2 systems [including PLC (e.g. Siemens S7), DCS (e.g. Siemens PCS7) and Process Analytical Tools (PAT) and Data infrastructure].
- Technical knowledge on Pharma Fill Finish processing and batch environment on DCS systems.
- Technical knowledge on interfacing between ISA-95 L2 and L3 systems.
- GMP knowledge on GAMP5 and CSV to support systems validation in projects.
Janssen Pharmaceutica N.V. (7555)