Validation Engineer

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).      

Job Description:

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

• • 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 relate 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

• • Bachelor’s degree in engineering or a technical discipline required
  • 2+ years of validation experience in the Pharmaceutical Industry
  • Comfortable with a 24/7 manufacturing environment
  • Works well with others within a team and takes accountability
  • Can handle a high-pressure, high-stress work environment
  • Result-driven and self-motivated
  • Strong interpersonal and communication skills (verbal and presentation)
  • Organized with strong computer literacy, such as MS Word, Project, Excel, etc.

Desired Hard Skill Sets (via Internships/Co-Ops):

• • Familiarity with Validation principles and executable deliverables (i.e. Requirements, Design, Testing, Reports, etc.)
  • C&Q and/or CSV experience, ideally around Data Integrity and CFR Part 11 Electronic Records and Signatures
  • Project Management experience with the ability to lead and drive projects to completion autonomously

Other Requirements

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