SAP System Process Specialist (CVRM)

Roche•Holly Springs, NC

61d•Hybrid

About The Position

ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity A System Process Specialist is being hired to participate in Greenfield Project execution and then support the facility after going live. The role will become member of SAP deployment team for Holly Springs and post go live become site first level support. Candidate will bring experience from one or more of following L4 business processes: EWM (Warehouse), Make, Plan, Asset, Quality Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. What You'll Do A Systems Process Specialist acts in the 1-Stop-Shop and is part of the support, continuous improvement and onboarding and adoption value streams. The Systems Process Specialist has a profound process understanding and is collaborating with the Business Support Community to continuously improve business processes and underlying IT applications. By this, he/she acts as a trusted adviser of the end-user for any kind of inquiry as well as a bridge between the end user and other roles in the various support layers and can raise incidents on behalf of the user area or work with managers to train users . The role is specialist on a specific operation process area and is providing end-user support based on in-depth and long time professional experience in this domain. Examples of domains include Plan, Make, Quality, EWM (Warehouse), Assets etc. In projects the Systems 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

Bachelor’s degree in Informatics, Engineering, or equivalent.
5+ years of experience with SAP R3.
Must have experience in biotech/pharmaceutical manufacturing GMP domain.
Knowledgeable about integration with enterprise business systems (SAP, MES, LIMS, etc.) and data integrity concepts.
Strong analytical skills for effective troubleshooting and problem solving.
Candidates must be self-driven and able to work well with others as a team member.
Strong technical writing and verbal communication skills.
Excellent customer service skills and delivery through agile mindset, stability, flexibility, and speed.
Passion for learning and sharing/leveraging best practices.
Eager to explore new technology and have the ability to learn new concepts.

Nice To Haves

Experience or familiarity with ASPIRE is a plus.

Responsibilities

End User Operation Support Performs Level 1 On Site/Remote support and troubleshooting of applications, primarily focused on SAP R3 and ASPIRE but could expand to PI, MES, etc.
Acts as Point of Contact for End User/business stakeholders in terms of business requests and IT related issues.
Triages, prioritizes requests and tries to identify the nature / root cause of an issue (handling issue, data issue, authorization issue, IT issue).
Distributes application issues and non-application issues that cannot be solved by him/her to the 2nd level and/or Global Team support.
Coordinates end user groups and escalation management.
Follows up on IT Service tickets to resolve issues in a timely manner.
Supports issue clarification on request of 2nd level and/or Global Team support.
Validates the resolution proposals and performs the necessary test in case tests are required.
Cooperates with 2nd level and/or Global Team support during analysis of reported incidents.
Maintains close coordination and communication with End User/site business stakeholders for major incidents.
May be a role owner for local roles.
Performs interface monitoring (business errors).
Executes complex or critical system actions.
For new IT initiatives/product/system roll out/Go Live to site, provides on site/remote on call support per business requirement such as adopting business shift pattern during initial roll out and stand down to remote On Call post Hyper Care after successful roll out.
Supports Global/Enterprise and Local ITOT application/systems.
Supports site audits and inspections, planned/unplanned events, and implementation of corrections, etc. as a Subject Matter Expert.
Provides 24x7 routine operation service support per Service Level Agreements to business.
Adheres to the requirements specified in IT related Roche's quality policies/quality standards or related SOP.
Continuous Improvement Supports/Leads Continuous Improvement opportunities related to ITOT applications/system.
Regular exchange with the Support network and or BPMs 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 eventually delivery of the added value to the End User.
Embodies PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.
Onboarding & Training Coordinates and conducts End User training.
Supports user authorization workflows (e.g. request, verify training, approve).
Adds information to the knowledge base.
Creates/Reviews Knowledge Articles.
Creates/Reviews training material.
Initiates knowledge management process.