Validation Engineer (Indianapolis)

Validation Engineer Medical Device Manufacturing

Indianapolis, IN | Onsite

Are you passionate about building medical solutions that truly matter? At our Indianapolis facility, we design and deliver life-saving medical products, from automated drug delivery systems to complex device assemblies. Were growing our Validation team and are looking for a Validation Engineer who thrives in a regulated environment and is eager to make an impact in healthcare innovation.

This is not just another engineering job. Its a chance to contribute to products that end up in the hands of patients worldwide devices like auto-injectors that provide life-saving medication in critical moments. Youll be part of a collaborative team that values quality, documentation excellence, and data-driven decision making.

What Youll Do

• Develop and author Validation Plans (VPs) and protocols for all phases of the validation lifecycle.
• Execute test protocols, analyze data using statistical tools / software (Minitab, etc.), and communicate insights.
• Lead and schedule Validation Review Board (VRB) meetings, review and approve validation documentation, and allocate resources across projects.
• Support process and equipment qualifications (IQ, OQ, PQ) and test method validations.
• Partner with medical device customers to deliver validation processes that meet regulatory expectations.
• Maintain documentation in compliance with FDA 21 CFR 820, GMP, and ISO13485 requirements.
• Mentor other engineers on validation practices and contribute to continuous improvement initiatives.

What Were Looking For

What Success Looks Like

In the first 3 months : Youll establish yourself in VRB meetings, support protocol / report generation, and contribute to validation for commissioning production systems.

By 6 months : Youll lead VRB meetings, train peers in validation practices, and support lean manufacturing initiatives.

By 12 months : Youll be championing the validation program, guiding team members, and driving continuous improvement across the validation lifecycle.

Schedule & Location

If youre looking for a role where your engineering skills directly contribute to patient well-being, while also enjoying a supportive and balanced workplace, this could be the right move for you.