ITOT System Process Specialist

Roche•Philadelphia, PA

About The Position

Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? This role could be for you! We Make Medicines! Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as leveraging new technologies. The Opportunity You as a System Process Specialist (SPS) will be acting in the First Level Support / One Stop Shop and are part of the support, continuous improvement structure. The System Process Specialist has a profound process understanding and is collaborating with the Business Community to continuously improve business processes and underlying IT Make, Assess & Release applications. By this, you act as a trusted adviser of the end-user/key-user as well as a bridge between the end user and other roles in the Informatics support layers. The SPS can raise incidents on behalf of the user area or work with Process Owner & other local business roles to train (key-)users. In projects, the System Process Specialist can also represent the interests of the systems user group and has the responsibility of coordinating and bringing input from the area of responsibility to the project and communicating project goals, information and progress back to the business areas.

Requirements

Bachelors degree in Information Systems, Automation or related experience
6 years professional experience in complex business environments and GxP environments
Ability to facilitate training for end-users in specific area (refresh and new)
Solid knowledge about business processes in the area of manufacturing & laboratory systems as well as about local specifics and GxP processes and procedures (e.g. clean rooms and gowning procedure)
Possesses in-depth conceptual and practical knowledge in the area of manufacturing & laboratory systems and basic knowledge in related fields
May lead sub-projects or participates on larger project teams; has on-site responsibility for ongoing activities/goals and product portfolios
Expert knowledge about application functionality, expected application behavior as well as known issues or workarounds
Good networking and communication skills

Responsibilities

End-User-Support Manufacturing & Laboratory Systems
End to End accountability for Make, Assess & Release System support
Responsible for 24/7 on-call, nights and weekends on a rotational basis
Log incident/requests into a ticket system for further processing
Triages, prioritizes incidents/requests and performs root cause analysis in problem management (handling issue, data issue, authorization issue, IT issue)
Coordination of End User groups and escalation management as required
Validate the resolution proposals and performs the necessary test in case tests are required on request of the 2nd level support
System Owner role for local systems with responsibility for providing an IT system or Device based Business requirements
Interface Monitoring (Business Errors)
Support Implementation of new Systems and Equipment
Data Integrity / Cybersecurity activities to guarantee IT security, integrity and continuity
Continuous Improvement of Manufacturing & Laboratory Systems
Regular exchange with the Support network and or Business Process Experts (BPE) on support cases, best practices and process improvement proposals with network relevance
Helps the End User to submit new ideas for process improvements, allowing a comprehensive approach for assessing both the process interdependencies as well impact to all underlying systems
Describes the full lifecycle of an integrated Change process to Business Process with System impact. This Framework combines the Assessment of the requirement, build and test work as well as deployment and possibly delivery of the added value to the End User
Support Processes & Tools for Laboratory Systems
Local Manufacturing Systems and Application Support for e.g. PI Historian, MES, ERP
Local Labsystem and Lab Equipment Bundle, Application Support for e.g. Ambr, QuantStudio, Benchling
Local Support of Informatics Products e.g. Central Label Management Software, Nextlab, Labx, Labware, Smartline Data Cockpit, Unicorn
Use of Service Now for incident, problem, request and change management