C

Validation Engineer

Accepting applications

CBSbutler · Indiana, United States, North America

Full-Time Senior aiarmate
Posted
18 Apr
Category
Test
Experience
Senior
Country
United States

Role - Level II Validation Engineer

Location – Indianapolis, IN


My client is seeking a Level II Validation Engineer/Specialist to join its team. In this role, you will report to the Site Manager and work across one or more project teams, supporting validation and qualification activities within regulated environments.


This is a hands-on, execution-focused role suited to someone looking to build on their experience within pharmaceutical or GMP settings.


Responsibilities


  • Apply technical, quality, and scientific principles to support validation activities in line with industry and client requirements
  • Work collaboratively within project teams to deliver against defined timelines and objectives


Develop validation documentation, including:

  1. Requirements and specification documents
  2. IQ/OQ/PQ protocols
  3. Summary and validation reports


  • Execute validation protocols, identifying and resolving deviations or non-conformances
  • Support change control processes across multiple projects
  • Contribute to maintaining compliance with GMP and regulatory standards


Qualifications


  • Bachelor’s degree in Engineering or a related discipline (Biomedical, Chemical, or Mechanical preferred)
  • 1–2 years of experience within pharmaceutical or other regulated environments, ideally within validation or CQV
  • Experience with change control, deviations, and CAPA processes
  • Strong communication and interpersonal skills, with the ability to work effectively with clients and cross-functional teams
  • High attention to detail and strong documentation skills
  • Exposure to cleaning, sterilisation, or decontamination validation
  • Experience within device assembly or packaging environments


Looking forward to hearing from you!