Staff Validation Engineer

Performance Validation; Indianapolis (IN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Biannual profit sharing

ESOP

401(k) with company match

Medical, dental, and vision coverage

Disability and life insurance

Paid vacation and holidays

Cellphone stipend

Job summary

Performance Validation in Indianapolis seeks a Staff Validation Engineer to join project teams and perform IQ/OQ/PQ, develop validation documentation, and support client engagements.

You will learn to apply FDA regulations and build expertise across validation disciplines while traveling to client sites, with opportunity for career growth through our defined levels.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field (or equivalent nuclear navy military training).
• High attention to detail; documentation errors have real consequences.
• Strong written and verbal communication skills interacting with client engineers and site personnel.
• Professionalism and dependability; consulting means representing PV on client sites.
• Willingness and enthusiasm to travel; could be 30–50% depending on clients' needs.
• Preferred engineering disciplines include Biomedical, Chemical, and Mechanical Engineering.

Responsibilities

• Travel to client facilities and perform hands‑on qualification and verification activities (IQ/OQ/PQ).
• Develop technical documentation including User Requirements, Risk Assessments, Test Protocols, and Summary Reports.
• Learn to apply FDA regulations (21 CFR Parts 11, 210/211, and 820) and cGMP to client systems.
• Perform system walk‑downs in manufacturing environments (field work, stairs, ladders, confined spaces, lifting).
• Support identification and resolution of test failures and non‑conformances.
• Build expertise in technical disciplines such as thermal mapping, computer systems validation, or process validation.
• Travel to client sites typically several days per month, with more travel during active projects.

Skills

Curiosity

Attention to detail

Written & verbal communication

Client-facing

Independence

Travel willingness

Education

Bachelor's degree in Engineering, Life Sciences, or related technical field

Equivalent nuclear navy military training

Job description

Position: Staff Validation Engineer

Location: Indianapolis, IN

Job Id: 359

# of Openings: 1

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.

What We Do

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.

What You'll Do

From day one, you'll be embedded in project teams alongside experienced engineers, learning by doing on real client engagements. Over time, you'll take on increasing responsibility across the full validation lifecycle:

• 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
• This role involves travel to client sites, typically several days per month, with more intensive travel during active project phases.

What We're Looking For

We don't expect you to know validation. We expect you to be the kind of person who can learn it and thrive in a client‑facing, project‑based environment.

That means:

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

What We Offer

Being 100% employee‑owned isn't a footnote; it means that when PV does well, you do well. Our compensation and benefits reflect that:

• Biannual profit sharing; you share directly in the company's success
• Employee Stock Ownership Program (ESOP) — you build equity in the company over time, at no cost to you
• 401(k) with company match
• Medical, dental, and vision coverage
• Disability and life insurance
• Paid vacation and holidays
• Cellphone stipend

And we invest in your development:

• 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

Why PV

We're a mid‑sized firm with a long track record and a genuine culture of ownership in every sense of the word. Our engineers aren't siloed into one product or one facility. You'll see the inside of facilities most engineers never encounter, build expertise that's valued across the life sciences industry, and do it alongside people who have chosen to build their careers here.

We also know that consulting requires give and take. We ask a lot of our engineers, and we work hard to make it worth it.

Qualified candidates must be legally authorized to work in the United States. Performance Validation does not anticipate providing visa sponsorship for this position.

Performance Validation is an Equal Opportunity Employer

We believe in the dignity, value, and potential of every individual. Performance Validation provides equal employment opportunities to all employees and applicants and makes employment decisions based on qualifications, merit, and business needs.

We do not discriminate on the basis of race, color, religion, creed, national origin, citizenship status, age, sex, pregnancy, sexual orientation, gender identity, marital status, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law. Performance Validation is committed to maintaining a workplace free from discrimination, harassment, and retaliation. We prohibit conduct that demeans, intimidates, threatens, or creates an offensive work environment based on any protected characteristic. Reasonable accommodations are available for qualified individuals with disabilities throughout the application and employment process.