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IT & Validation Talent
Engineers who understand the regulated part.
Plenty of IT contractors can build the system. Far fewer can produce the validation evidence, hold the data integrity line and survive the audit that follows.
Overview
Engineers who understand the regulated part
We place CSV specialists, LIMS and eQMS engineers, automation and integration developers, and infrastructure people who have worked inside GxP environments before.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
Capabilities
Roles we place
Validation Engineers
CSV, IQ/OQ/PQ and periodic review specialists.
Systems Specialists
LIMS, eQMS, ERP and MES implementation and support.
Developers
Full-stack and integration engineers building validated applications.
Infrastructure & Security
Cloud, network and security engineers for regulated estates.
What we screen for in regulated IT
A strong developer or systems engineer is not automatically a good fit for a GxP environment. Before we put anyone forward we check that they understand the regulated part of the job, not just the technology.
- Validation evidence. Experience writing or executing user requirements, functional specifications, risk assessments, IQ/OQ/PQ protocols and traceability matrices, and closing out deviations found during testing.
- Data integrity. A working grasp of ALCOA+ principles, audit trail review and access control, and how those expectations show up in inspections.
- Regulatory frameworks. Familiarity with 21 CFR Part 11, EU GMP Annex 11 and the GAMP 5 approach, including where a risk-based, Computer Software Assurance mindset reduces unnecessary testing.
- System experience. Hands-on time with the platform types life sciences teams run, such as LIMS, eQMS, ERP, MES, chromatography data systems and clinical systems.
- Change control discipline. Evidence that the candidate works within change control and periodic review rather than around it.
Ways to engage
We supply IT and validation specialists as individual contractors, on a contract-to-hire basis, as direct hires, or as a small project team working to a defined scope. If you are not sure which model suits a project, describe the problem and a specialist will give you a straight recommendation.
Typical requests
Common examples include a validation engineer to take a new LIMS through qualification, an eQMS administrator to support go-live and the first months of use, a periodic review backlog that needs clearing before an audit, or an integration developer who can document interfaces to the standard a validated system requires. See our IT services if you need us to deliver the outcome rather than supply the people.
Send us one requisition.
Judge us on the shortlist, not the sales deck.