Janssen Supply Chain IT Lead: Regional Serialization and Integrated Services Job

Job description

Janssen Supply Chain IT Lead: Regional Serialization and Integrated Services-00000WWNDescription‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science
- bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
Janssen Supply Chain IT is part of the world's largest healthcare company, Johnson & Johnson, and enjoys an international reputation for pharmaceutical innovation and quality.
Manufacturing and Supply Chain Solutions is a global team with Janssen Supply Chain IT organization. The group is currently recruiting an IT Lead Analyst. The Serialization and Integrated Service lead will be responsible for the delivery and support of serialization and various other integration services to Janssen Supply Chain manufacturing sites. This will include Production Execution Management services that are delivered for different IT manufacturing solutions (serialization site repository; Integration systems; labeling/printing systems and others).The IT lead will be responsible for partnering with various internal IT organizations (Logistics, Infrastructure/Hardware, Application services, IT portfolio management, etc) as well as automation groups, and other business groups to develop, implement and maintain services and service models that will provide manufacturing application support for the pharmaceutical operations network. And in addition this individual will help develop, continue to maintain, and execute against technological roadmaps and strategies that ensure standardization and subsequent value to the business while assuring that Lifecycle Management direction is adhered to across the multi-site network.
This position will be located in EMEA at one of the following Janssen Supply Chain manufacturing sites: Latina, Schaffhausen, or Beerse. The position will require up to 30% travel (domestic and to Asia sites in China and Korea).The Serialization and Integrated Services IT Lead will be responsible for the following:
- Analyzing business problems, opportunities, and challenges, factoring in a strong understanding of the technical architecture of the serialization solution and the underlying drivers of the business associated with serialization capabilities.
- Lead assignments and projects of moderate, to high complexity, ensuring that project plans are defined and executed to achieve the business and technical objectives while following JnJ system development lifecycle methodology, risk assessment and validation rules or compliance guidelines as needed.
- Technical assistance to manufacturing sites by providing support to the local business and/or technical resources in case of application issues during local installations.
- Developing, maintaining and executing processes related to the support and service models including: Incident management, Change control, and Configuration management. As well as responsibility for the problem management process for EMEA serialization standard platform
- Participating in the development and maintenance of the Service Design Package which includes but is not limited to, Functional Requirements, Service Level Requirements, Service Processes for the EMEA regional serialization solution.
- Validation engineering services to ensure compliance of the EMEA solution including: Creating and reviewing Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise. This includes supporting and executing tests needed to release systems for local installations.
- Partnering within a global matrix organization to successfully achieve business goals. Develop networks with internal and external IT and Business partners and proactively manages expectations.
- Collaborating with the Vendor(s) to support creation of validation deliverables and SW packages to assure full compliance with JnJ quality and technical standards. In particular, the individual will need to diligently work proactively with the Vendor challenging technical choices during development phase to prevent issues during execution phase.
Qualifications
- BA/BS Degree is required
- 6+ years of experience supporting pharmaceutical manufacturing IT systems. May include MES application, packaging control systems, tracking systems, and/or Printing/labeling solutions
- Experience and knowledge in various manufacturing automation technologies including SCADA, and/or Batch Execution Systems
- Understanding of various technologies used to integrate SAP to production execution and/or production control systems. Specific knowledge of SAP MII is a plus.
- Understanding of various technologies used to manage and deliver serialization, track&trace, and/or product genealogy capabilities to cope with emerging market regulations. Specific knowledge of Antares Tracking System is a plus
- Experience with design, configuration, testing, and validation of Manufacturing IT system and/or process control systems
- including knowledge of serialization and track and trace capabilities required for meeting general regulations
- Experience with industry standards such as GS1 (Global Standards organization) is preferred
- Knowledge and understanding of ISA S95 Standard for integrating shop floor to enterprise systems
- Experience and knowledge in computer system validation. Ability to write and execute test and qualification plans.
- Ability to work independently and proactively being focused to deliver high performance and value to the business
- FPx, PMI and/or ITIL certification is an asset.
- Ability to communicate effectively with all levels and functional areas of business partners is required
- Fluent knowledge of English
- Travel: 30% of the timeSTEP-BEPrimary Location:Europe/Middle East/Africa-Belgium-Antwerp-BeerseOther Locations:Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Italy-Lazio-LatinaOrganization: Janssen Pharmaceutica N.V. (7555)Travel:Yes, 25 % of the TimeJob Function: Info Technology