Veeva Change Control Engineer / Quality Lead


Indianapolis
Permanent
Negotiable
Automation and Controls
PR/551872_1751895914
Veeva Change Control Engineer / Quality Lead

A prominent organization in the life sciences sector is seeking a Veeva Change Control Engineer to join a collaborative, cross-functional implementation team. This role is ideal for an engineering professional with a strong background in change control processes and experience working in regulated environments.

Position Summary

As a key contributor to the implementation team, you will help shape the configuration and deployment of a Veeva-based Change Control system. You'll play a central role in system testing, documentation, training, and user support throughout the project lifecycle.

Key Responsibilities

  • Participate in team discussions and requirements workshops to provide engineering insights.
  • Conduct informal system testing and provide feedback to improve configuration.
  • Identify and communicate engineering needs and challenges within the change control process.
  • Act as a subject matter expert (SME) for specific procedures and tools, contributing to the development of SOPs and training materials.
  • Collaborate with integration partners to refine documentation and ensure alignment with operational standards.
  • Execute formal validation test scripts and document results in accordance with internal quality procedures.
  • Assist in training sessions for key users and provide support during system rollout and stabilization.

Qualifications

  • Bachelor's degree in Engineering or a related field.
  • Hands-on experience with authoring and executing change controls.
  • Familiarity with core engineering disciplines such as maintenance, reliability, equipment qualification, process automation, and monitoring.
  • Solid understanding of Good Manufacturing Practices (GMPs) and experience supporting GMP-compliant operations.
  • Experience with systems like IBM Maximo or ServiceNow is a plus.
  • Prior experience with Veeva QMS or TrackWise is preferred.
  • Applicants must be U.S. citizens and not require sponsorship now or in the future.

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