Digital C&Q Application Engineer

Job Title- Digital C&Q Application Engineer
Job Location- Princeton NJ (Hybrid In a week minimum 3 days work from office)

Job Description-
Qualification & Experience:
Experience implementing or supporting C&Q validation quality or other enterprise GxP applications preferably in the pharmaceutical/biotech industry.
Enterprise application implementation and production support experience.
Experience working with SaaS applications and software vendors.
Understanding of GxP and CSV/CSA processes.
Strong troubleshooting problem-solving communication and organizational skills.
Kneat Veeva ValGenesis or similar C&Q/quality application experience preferred.
Ability and willingness to learn a new application and transition from implementation support into ongoing application support.

Desired Candidate Characteristics:
Ability to work closely with the IT Application Owner and cross-functional teams to successfully deliver application capabilities.
Strong collaboration and communication skills.
Ability to learn new applications technologies and business processes quickly.
Strong ownership organization and follow-through.
Ability to work Consultantly while knowing when to engage the Application Owner vendor business or technical teams.
Commitment to delivering quality solutions within schedule
Key Responsibilities:
Application Implementation & Deployment Support
Support the IT Application Owner in planning and executing the Kneat implementation and deployment.
Coordinate with the Kneat product vendor and internal IT business and Quality/Validation teams.
Support application configuration technical design reviews testing UAT validation deployment and go-live activities.
Track technical issues risks dependencies and action items and help drive them to resolution.
Provide IT support during implementation testing cutover and hypercare.
Application Knowledge & Transition
Develop a strong functional and technical understanding of the Kneat C&Q platform through vendor knowledge transfer implementation activities and hands-on experience.
Build application support knowledge and documentation required for ongoing IT ownership.
Support the transition of the application from implementation into steady-state support.
Application Support & Maintenance
Provide ongoing Kneat application support following go-live.
Troubleshoot application issues and coordinate resolution with the product vendor and internal technical teams.
Support incidents break/fix activities enhancements releases upgrades and patches.
Serve as a technical point of contact for the application and support business users as needed.
Documentation & Compliance
Create and maintain technical and application documentation.
Support GxP CSV/CSA security and IT compliance activities.
Review and execute validation activities and supporting documentation as required.
Collaboration
Work closely with the IT Application Owner business stakeholders Quality/Validation IT infrastructure security integration teams and product vendor to ensure successful delivery and ongoing operation of the application

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Required Experience:

IC