Staff Validation Engineer

Performance Validation • Indianapolis, IN

1d • Onsite

About The Position

Start Your Engineering Career Where It Actually Matters Most. Engineering jobs ask you to specialize early and stay in your lane. This one is different. At Performance Validation, you'll work directly in FDA-regulated facilities such as pharmaceutical plants, medical device manufacturers, biotech labs, etc., making sure the systems and processes that produce life-saving products actually work the way they're supposed to. It's hands-on, technically demanding, and genuinely important work. We hire engineers straight out of college and teach them everything. If you're sharp, curious, and ready to grow fast, we'll invest heavily in making you an expert. Performance Validation is a 100% employee-owned consulting firm with over 30 years of experience providing Commissioning, Qualification, and Validation (CQV) services to the life sciences industry. Our engineers work on-site with pharmaceutical, biotech, and medical device clients across the U.S. and internationally, helping them meet rigorous FDA and industry standards. We have teams in Indiana, Michigan, Illinois, Kansas, Washington, Wisconsin, and North Carolina.

Requirements

• A Bachelor's degree in Engineering, Life Sciences, or a related technical field (or equivalent nuclear navy military training)
• Genuine curiosity and a drive to understand how things work
• High attention to detail; in this industry, documentation errors have real consequences
• Strong written and verbal communication skills; you'll be interacting with client engineers, quality managers, and site personnel from day one
• Professionalism and dependability; consulting means representing PV on client sites, not just in our offices
• Willingness and enthusiasm to travel; could be 30-50% depending on clients' needs
• Comfort working independently once you've been trained, and the judgment to ask for help when you need it
• Qualified candidates must be legally authorized to work in the United States.
• Performance Validation does not anticipate providing visa sponsorship for this position.

Nice To Haves

• Preferred engineering disciplines include Biomedical, Chemical, and Mechanical Engineering, though we've built great careers with graduates from a wide range of technical backgrounds.

Responsibilities

• Travel to client facilities and perform hands-on qualification and verification activities, including Installation, Operational, and Performance Qualifications (IQ/OQ/PQ)
• Develop technical documentation including User Requirements, Risk Assessments, Test Protocols, and Summary Reports under the guidance of senior engineers
• Learn to apply FDA regulations (including 21 CFR Parts 11, 210/211, and 820) and cGMP principles to real-world client systems and processes
• Perform system walk-downs in manufacturing environments — this is field work, and may involve stairs, ladders, confined spaces, and moderate lifting
• Support identification and resolution of test failures and non-conformances
• Build expertise in a technical discipline such as thermal mapping, computer systems validation, or process validation — depending on your interests and the needs of your team

Benefits

• Competitive base salary
• Biannual profit sharing
• Employee Stock Ownership Program (ESOP)
• 401(k) with company match
• Medical, dental, and vision coverage
• Disability and life insurance
• Paid vacation and holidays
• Cellphone stipend

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level