Validation Engineer

Validation Engineer (Level I)

PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water / Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis).

The Validation Engineer will manage various commissioning, qualification, and / or validation facets within our client's Biotechnology and Pharmaceutical sites. This support service will work within the client's validation, project management, quality, and / or automation department team(s). Position responsibilities / essential functions include :

• Develop and / or drive to completion the following Commissioning and Qualification (C&Q) deliverables : project validation plan, risk assessments and project strategies, requirements, functional design specifications, software / hardware design specifications, impact assessments, trace matrix, test cases / scripts, engineering studies, and summary reports.
• Thoroughly understand the commissioning and qualification process and influence cross-functional team members to ensure adherence to governing policy and procedure.
• Ensure change management is properly assessed throughout the course of the project and all documentation impacted is maintained. This includes changes due to evolving design and failures during test execution.
• Lead and participate in project review meetings such as design reviews, alignment sessions, test strategy, test execution reviews, project status, and qualification review meetings.
• Manage and report project scope and budget considerations as it relates to C&Q.
• Develop and maintain documentation within an electronic lifecycle management system capable of paperless execution.
• Support the execution of large capital projects that contribute to the expansion of pharmaceutical manufacturing. Projects may include the following types of equipment : active pharmaceutical ingredient manufacturing, filling operations, delivery device assembly, packaging, facilities and utilities, and automation.

Requirements include :

Desired hard skill sets (via internships / co-ops) include :

Other requirements include : Location : Indianapolis Travel : Up to 40% of the time to various suppliers, collaborators, and client sites outside of Indianapolis