1099 consultant · ~120–600 hrs per funded award · $60–$95/hr · Remote (U.S.)

Computer System Validation & GxP Quality Lead

Lead validation and GxP quality for the regulated systems we build: CSV and CSA approaches, 21 CFR Part 11 controls and GAMP 5 documentation that holds up in an inspection.

About Precision Federal

Precision Federal is a small business building AI, data and software systems for government agencies. The company’s founder loves God, and the company is built on Christian faith: every number we publish is real, every claim we make is verifiable, and the work is done with excellence as service to God. Faith is welcome here and openly shared.

How this role works

You join the bench. You apply with your hourly rate, weekly hours and start time, and we may name you on proposals that match this role. If we don't win, you owe nothing.
A contract is awarded. The award funds the team named in the proposal. Your engagement begins at the hourly rate we agreed on.
You work remote, paid from the contract. ~120–600 hrs per funded award — and if no award ever funds, you owe nothing and lose nothing.

What you'll do

Write validation plans, risk assessments, requirements traces and test protocols
Apply CSA and GAMP 5 risk-based approaches to cloud and data systems
Assess electronic records and signatures against 21 CFR Part 11
Prepare systems and teams for audits and regulatory inspections

Required qualifications

5+ years in computer system validation or GxP quality assurance
Hands-on 21 CFR Part 11 and GAMP 5 work
Experience validating software in a regulated life sciences or public health setting
U.S. citizen or lawful permanent resident (U.S. person)
Willing to be named on a federal proposal with a one-page resume, and to sign a short letter of commitment

Preferred qualifications

FDA, NIH, CDC or BARDA program experience
Validation of cloud, SaaS or AI/ML systems
ASQ CQA or another quality certification

Compensation & structure

1099 consulting engagement. $60–$95 per hour; you tell us the rate you are asking when you apply. Hours are funded by federal contract awards — this seat is scoped at roughly 120–600 hours per funded award, fully remote. Work and pay begin only if the contract is awarded — no award, no hours, no obligation.

Join the bench — Computer System Validation & GxP Quality Lead

Every application is read.

This is a bench, not a job offer. Work starts when we win a contract that needs you.
We may name you on proposals. If that contract is awarded, you do the role at the rate and hours we agree on.
Paid hourly as a 1099 contractor; full-time roles may be W-2. If your background fits, we will email you.

First name *

Last name *

Email *

Phone *

Work authorization *

LinkedIn or portfolio link

What state do you live in? *

Resume (PDF or Word) *

Questions

Answer from your own experience. A few sentences each is plenty; be specific and tell us what you did yourself.

1. Cover letter. In your own words, tell us about yourself: your background, the work you do best, the values that guide your work, and why this role interests you. *

2. Describe the validation or quality project most like this role: the system, the regulations, your role and the result. *

3. Which standards, methods and tools do you use hands-on (CSV, CSA, GAMP 5, 21 CFR Part 11, EU Annex 11, validation management systems)? *

Rate and availability

Your hourly rate (USD) *

Target rate: $60–$95 an hour.

Hours per week you could give on an awarded contract *

If you are named and we win in the next 12 months, how soon could you start? *

May we name you on proposals for this role, and if we win, will you do the work at the rate we agree on? *

Precision Federal was founded on Christian values. Our faith in God shapes how we work: we talk openly about faith, and we share fellowship together. Taking part is always voluntary. As we get to know you, you’re always welcome to share your own faith with us.

Questions? careers@precisionfederal.com · See all open roles