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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