Staff Validation Engineer

PerfVal Labs, Inc. • Indianapolis, IN

1d • Onsite

About The Position

This role is for a Staff Validation Engineer who will work directly in FDA-regulated facilities such as pharmaceutical plants, medical device manufacturers, and biotech labs. The engineer will be responsible for ensuring that the systems and processes that produce life-saving products function correctly. Performance Validation hires engineers directly out of college and provides extensive training, investing heavily in their development to make them experts. The company is a 100% employee-owned consulting firm with over 30 years of experience in Commissioning, Qualification, and Validation (CQV) services for the life sciences industry. Engineers work on-site with clients across the U.S. and internationally, ensuring compliance with rigorous FDA and industry standards.

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
• Strong written and verbal communication skills
• Professionalism and dependability
• Willingness and enthusiasm to travel (could be 30-50%)
• Comfort working independently and the judgment to ask for help when needed
• 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 graduates from a wide range of technical backgrounds have built successful careers.

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
• 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, which 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
• Travel to client sites, typically several days per month, with more intensive travel during active project phases.

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
• Structured mentorship from senior engineers on every project team
• Internal and external training programs, including industry certifications
• A clear path to advancement through our defined career levels
• Exposure to diverse industries, clients, and technical disciplines across our national footprint

What This Job Offers

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