EDX OR 3DEXPERIENCE Key User

Responsibilities

Core Accountability

The Site Implementation Key User is accountable for realizing the LEDP (3DX) tool usage at the site.

He/she acts as the primary implementation specialist for the local MSAT organization and the global LEDP function to introduce detailed process information into the platform.

Scope

In scope

Out of scope

Key Responsibilities

LEDP Site Process Information Owner

LEDP Usage monitoring

User Enablement & Access Support

LEDP Technical Accuracy and Facility Harmonization Management

Feedback & Continuous Tool Improvement

Act as a support of Data steward for data entry when required

Profile

• User support and enablement for the tool for Frankfurt /InsuLINK project needs
• Tool adoption and usage consistency in Frankfurt site
• Site readiness for LEDP releases
• Understand all needs of stakeholders
• Understand the technical background, capabilities and requirements of 3DX/LEDP
• LEDP functional usage
• Understand the different use cases and the overlaps
• Understand differences in insulin manufacturing process and important data structures
• Collect all relevant process information and bring them together in a harmonized layout
• Restructure the process information into an overall applicable form
• Import and integrate the process information into the LEDP platform to launch business processes
• First-line functional support and issue qualification (responsibility of LEDP core team)
• Decision-making on global LEDP roadmap or architecture
• Acts as collection point of process information and systems for all stakeholders
• Interfaces with:
• Legacy operations team
• InsuLINK Team
• LEDP global team
• Site Launch Leaders (tool usage & deployments)
• Digital LEDP Product Owner
• Represent the special needs of all stakeholders and product stewards for Frankfurt/InsuLINK LEDP usage
• Ensures the implementation of all relevant information and the correctness
• Ensure LEDP is used according to defined functional usage guidelines (defined by LEDP global tem)
• Promotes system-based execution and limits off-tool workarounds
• Assess correct usage of:
• Workflows / Version approvals
• Status updates
• Data fields and attachments
• Ensure users:
• Make correct access and roles request in LEDP
• Approve Access request for site users in ServiceNow
• Coordinates:
• Onboarding of new LEDP users at site level
• Understand how to use the tool for their responsibilities
• Refresher training when recurring usage issues arise
• Acts as a local coach for LEDP usage.
• Participate in project meetings
• Collect and work out comparable process information of different project facilities
• Work out a naming convention and function based on LEDP-functionalities in accordance with global data & standardization guidelines, with support from Global Launch Engine team
• Perform exploration tests
• Ensure correct working while comparing different facilities
• Risk assessment of impact if comparing fails
• Implement and import all relevant process information for different facilities
• Ensure the completeness and data integrity of the information
• Communicates tool-related impacts to LEDP global key users
• Collects structured feedback on:
• Usability
• Missing functionalities
• Adoption barriers
• Submits and tracks:
• Improvement requests
• Defect reports
• Shares site-level feedback with global LEDP teams
• Experienced with LEDP/3DX implementation
• Able to restructure big amount of data and bring them organized in a harmonized way for all different facilities in the LEDP/3DX platform
• Collaborative mindset with the LEDP/3DX network
• Experienced with facility fit and facility harmonization
• Ideally: Experienced in GxP data management in a DS pharmaceutical environment
• Comfortable with digital platforms and structured workflows
• Able to manage many stakeholders focusing on specific target
• Able to construct a strong network at site production/operation level & global level
• Interested in personal development by supporting different functions

Project details

• Start: ab sofort
• Duration: 24 Monate
• Remote: remote
• Location: FRANKFURT, Deutschland, DE
• Rate: 85-85 EUR/h