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Two disciplines, one team.
Engineering and regulatory are not separate workstreams here. The same people who ship the code own the validation evidence for it. That's how documentation stops decaying and how audits stop being a separate project.
Careers
Help us build digital ecosystems the world can trust.
ITGxP works at the intersection of enterprise technology and regulated-industry compliance — the seam where shipping fast and proving correctness have to coexist. We hire people who think that's a problem worth their decade.
The stakes
What this work is for.
The systems we touch carry clinical data, manufacturing decisions, audit evidence, and patient outcomes. The companies we work with are trying to ship faster and stay defensible at the same time. That's the wedge.
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Disciplines under one operating model — engineering and regulatory.
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Coverage across timezones — incidents don't sleep, neither do we.
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Audit-ready documentation as the default delivery — not the upgrade.
Why this work is hard
The IT/GxP intersection is the place most consultancies pretend doesn't exist.
Engineering speed punishes documentation.
Shipping a feature and writing the validation evidence for it pull in opposite directions. We refuse to pick one. The answer is craft, not compromise — and it's a craft worth getting good at.
Regulatory expectations keep moving.
21 CFR Part 11, EU Annex 11, GAMP 5, data integrity guidance — the surface area changes every year. You don't learn this once; you keep learning. We hire people who like that.
Most tools weren't built for both.
Modern engineering tooling assumes the move-fast world. Validation tooling assumes the paper-trail world. Bridging them — without losing either property — is the day job.
The stakes are real.
Clinical trial data, manufacturing decisions, patient records. The downside of getting this wrong is not a retro — it's a regulatory finding or a recall. We treat the work like that matters, because it does.
Distributed by design
Where we work
A team, not a place.
ITGxP is distributed by design. We pair offshore delivery centers with onshore expertise so engagements run around the clock — under a single governance model and a single set of standards.
What stays constant: role-based access, structured documentation, and SLAs that don't bend at a timezone boundary.
- Hyderabad
- Lowell, MA
- + remote, worldwide
Operating principles
How we work.
We have opinions about this. Some you'll already agree with; some you might not. We'd rather you know them before you join than after.
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Documentation is a product.
URS, FRS, IQ, OQ, PQ — we treat them like code: versioned, reviewed, load-bearing. If our docs can't be picked up by a stranger and turned into an audit response, we've failed.
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Operate globally, govern carefully.
Distributed by design — with role-based access, secure remote-access controls, and structured handoffs you can prove on demand. Speed without governance is a future incident report.
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Bias toward inspection-ready.
Every system we touch should be defensible the day after we deliver it. Not because we expect an audit — because we expect to need the evidence eventually, and that day is always sooner than you'd guess.
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Help the team that has to live with it.
The downstream operator inherits everything we write. Our work is measured by how easy it is for them to run, change, and explain — not by how clever it looks in a slide.
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Honest about what's hard.
The IT/GxP intersection is genuinely difficult. We prefer naming the trade-offs over pretending they aren't there. That's how clients trust us with the next engagement.
Who you'd be working with
Before joining ITGxP, they did other things.
The team is intentionally heterogeneous. Engineers who became validation specialists. Inspectors who became architects. Operators who became engineers. The common thread is judgment under constraint.
A. Patel
Senior CSV Consultant
Before joining ITGxP I spent eight years validating ERP and MES systems inside a top-10 pharmaceutical manufacturer. Half my work was talking to inspectors; half was teaching engineers what inspectors actually look at.
S. Okafor
Cloud Solutions Architect
Before joining ITGxP I designed cloud architecture for a Series B biotech scaling lab informatics from one lab to nine. I learned that 'cloud-native' and 'validated' are not opposites — they just need to be planned together.
M. Hernández
Application Support Lead
Before joining ITGxP I ran a 24/7 incident response team at a payments company. The discipline transfers: it's not the alert that matters, it's whether the runbook is correct three months later.
J. Lin
Data Integrity Specialist
Before joining ITGxP I led the data integrity remediation for a contract manufacturer two months out from a planned FDA inspection. Nothing teaches you ALCOA+ like deadline pressure.
R. Aboud
Delivery Manager
Before joining ITGxP I managed offshore engineering pods for a European insurance group. The same governance patterns that work for insurance compliance translate surprisingly well to GxP.
K. Iyer
AI Operations Engineer
Before joining ITGxP I built predictive monitoring and automated triage tooling for an enterprise observability platform. Reducing noise is a craft — and it matters more in regulated environments than anywhere else.
Open roles
Now hiring.
Don't see your role? We're always interested in strong engineers and consultants — write to us anyway.
Senior CSV Consultant
Full-timeRemote · Global
Lead validation strategy and execution across pharma and biotech client systems.
Cloud Solutions Architect
Full-timeRemote · Global
Design and deliver cloud architectures for regulated and enterprise environments.
Application Support Engineer (L2/L3)
Full-timeOffshore Pod
Support enterprise applications with structured incident management and SLAs.
Data Integrity Specialist
Full-timeRemote · Global
Audit, assess, and remediate data integrity controls in regulated client systems.
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