Digital C&Q Application Engineer

Role: Digital C&Q Application Engineer
Location: Princeton, NJ (Hybrid, In a week minimum 3 days work from office)

Position Summary

C&Q Application Engineer for PDS Global Technical Services (GTS) IT Systems plays a crucial role in delivering IT capabilities and services that support our GTS functions, primarily Digital Commissioning and Qualification platform implementation. You will work collaboratively with colleagues to understand their information technology and digital enablement needs. This role involves interpreting business requirements from various business units and functional groups, understanding software development lifecycle in BMS, and delivering SaaS based application platform in collaboration with product vendor, PDS business and quality organization. Additionally, you will support the execution of Computer Systems Validation processes including but not limited to reviewing test scripts, executing test scripts, and reviewing technical documentation for the product to ensure BMS standards are met.

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

• 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.

Qualifications & 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.