Senior Validation Engineer – cGMP, CSV & Quality SME

Barry-Wehmiller Companies Inc.; Indianapolis, Northern (IN, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

BW Design Group is seeking a Validation Engineer to lead validation activities for equipment, utilities, and processes in a regulated setting. You will author protocols, participate in qualification activities, and provide expert guidance to cross-functional teams across projects.

The role requires 5+ years in validation within a cGMP environment, strong technical writing, and project coordination skills. On-site work in Indianapolis, with potential travel for project timelines.

Qualifications

• Requires Bachelor’s degree in Engineering, Life Sciences, or related field.
• Master’s degree preferred for advanced roles.
• Minimum 5+ years in validation or regulated environment.

Responsibilities

• Author, review, and approve validation protocols, reports, and documentation.
• Establish and maintain validation master plans and lifecycle documentation.
• Execute IQ/OQ/PQ protocols for equipment, utilities, and systems.

Skills

Technical writing

Regulatory knowledge

Project management

Communication

Independent work

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree preferred

Tools

Microsoft Office

Electronic validation systems

Job description

BW Design Group is seeking a Validation Engineer to lead validation activities for equipment, utilities, and processes in a regulated setting. You will author protocols, participate in qualification activities, and provide expert guidance to cross-functional teams across projects.

The role requires 5+ years in validation within a cGMP environment, strong technical writing, and project coordination skills. On-site work in Indianapolis, with potential travel for project timelines.