GxP Infrastructure Validation Specialist

GxP Infrastructure Validation Specialist | Contract | Remote UK

I'm supporting a global pharmaceutical client on a major SAP S/4HANA transformation and need two validation specialists to qualify the infrastructure behind it.

The infrastructure teams do not yet operate under GxP governance, so this is a chance to qualify the platforms and help put working controls in place, to a strategy set by the programme's GxP Validation Lead.

What you will do:

• Author qualification plans, risk assessments, IQ protocols and qualification reports

• Qualify cloud and hosted platforms, servers, networks, backup and restore, disaster recovery and access management

• Draft the procedures and templates infrastructure teams need to work in a GxP controlled way

• Support supplier and hosting provider assessments

What you will bring:

• GxP IT infrastructure qualification in pharma, biotech or medical devices

• GAMP 5, the GAMP IT infrastructure guidance, EU GMP Annex 11 and 21 CFR Part 11

• Qualification of cloud or hosted environments

• The ability to explain GxP requirements to technical teams new to them

Azure, AWS, ITIL or SAP hosting experience is a strong plus.

Start: November or December 2026

Remote UK with occasional workshops. Contract, inside IR35. Initial six months with extension expected.

If this looks relevant, message me directly or apply.