Digital C&Q Application Engineer

Cynet Systems•Princeton, NJ

1d•Onsite

About The Position

This role focuses on implementing and supporting C&Q (Commissioning & Qualification), validation, quality, or other enterprise GxP applications, with a preference for experience in the pharmaceutical/biotech industry. The position involves enterprise application implementation and production support, including experience with SaaS applications and software vendors. A strong understanding of GxP and CSV/CSA (Computer System Validation/Computer Software Assurance) processes is essential, along with excellent troubleshooting, problem-solving, communication, and organizational skills. The ideal candidate will be able to learn new applications quickly and transition from implementation support to ongoing application support. The role requires close collaboration with the IT Application Owner and cross-functional teams to deliver application capabilities, demonstrating strong ownership, organization, and follow-through. The candidate should be able to work independently while knowing when to engage relevant teams and be committed to delivering quality solutions on schedule.

Requirements

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.
Ability and willingness to learn a new application and transition from implementation support into ongoing application support.
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.

Nice To Haves

Kneat, Veeva, ValGenesis, or similar C&Q/quality application experience preferred.

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.