Digital C&Q Application Engineer

Job Title: Digital C&Q Application Engineer

Job Location: Princeton, NJ

Job Type: Contract

Pay Range: $50.00hr - $55.00hr

Job Overview:

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 independently 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

Application Knowledge & Transition

Application Support & Maintenance

Documentation & Compliance

Collaboration

• 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.
• 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.
• 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.
• 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.
• 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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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities