Validation Engineer

Validation Engineer – Pharmaceutical Manufacturing | VHP | Aseptic Processing
Location: Indianapolis, IN -OR- remote in Northeastern U.S.
Travel: Up to 60% (Local day trips and overnight travel throughout the Northeastern U.S.)
Are you a Validation Engineer with experience in pharmaceutical equipment validation, VHP systems, or aseptic processing?
We're partnering with an innovative manufacturer of advanced pharmaceutical processing equipment that is expanding its Validation Engineering team.
In this customer-facing role, you'll support cutting-edge pharmaceutical, biotech, radiopharmaceutical, and cell & gene therapy projects across North America. You'll lead equipment qualification, develop VHP decontamination cycles, and work directly with customers to bring highly specialized manufacturing systems online.
If you enjoy a mix of engineering, field work, customer interaction, and solving complex technical challenges, this is an outstanding opportunity to grow your career while working with advanced sterile manufacturing technologies.
What You'll Do
Lead equipment validation activities, including FAT, SAT, IQ, OQ, and PQ
Develop and execute Vaporized Hydrogen Peroxide (VHP/VPHP) decontamination cycles
Support commissioning, startup, and qualification of pharmaceutical manufacturing equipment
Work directly with customers at their manufacturing facilities throughout North America
Prepare validation protocols, reports, and GMP documentation
Ensure equipment and processes meet regulatory, quality, and customer requirements
Collaborate with engineering, quality, and project teams to deliver successful customer implementations
What We're Looking For
Required:
Proven experience in Validation Engineering
Equipment validation experience (cleanroom validation experience is also considered)
Experience with Vaporized Hydrogen Peroxide (VHP/VPHP) systems
Experience developing or executing decontamination cycles
Experience in aseptic processing or sterile pharmaceutical manufacturing
Experience preparing pharmaceutical validation documentation, including IQ/OQ/PQ protocols and reports
Strong communication skills and the ability to work directly with customers
Ability to travel up to 60%, including overnight travel throughout the Northeastern United States
Preferred:
Experience with Steris VHP generators
Pharmaceutical, biotechnology, or life sciences manufacturing experience
Knowledge of GMP and regulated manufacturing environments
Why You'll Love This Opportunity
Work with advanced pharmaceutical and biotechnology manufacturing technologies.
Own projects from installation through qualification and customer acceptance.
Make a direct impact on critical manufacturing environments supporting life-saving therapies.
Join a collaborative engineering team where your technical expertise is valued.
Enjoy a dynamic role that combines engineering, validation, customer interaction, and travel.
If you're passionate about validation, enjoy working directly with customers, and have experience with VHP, aseptic processing, or pharmaceutical manufacturing, we'd love to connect with you.

Work arrangement
Yes