The problem with most automation software in regulated environments
Validation isn't something you bolt on at the end. But that's exactly what happens on a surprising number of regulated automation projects. The developer writes the PLC code, gets it functionally working, and then someone - usually a very stressed validation engineer - has to work backwards to produce documentation that makes it look like the project followed a proper V-model lifecycle.
The result is documentation that technically exists but doesn't actually trace. The functional spec describes one behaviour, the code does something slightly different, and the test protocol tests a third thing. It passes internal review because everyone's too deep in it to see the gaps. Then it hits a customer audit or a regulatory inspection and falls apart.
This isn't a documentation problem. It's an engineering problem. The developer didn't understand what validation requires at the point where it matters - during design, not after commissioning.
How I work in regulated environments
I write the software design specification before I write a line of code. Not because a quality system says I have to, but because it's the only way to build software that does what it's supposed to do and can be proven to do so. The SDS describes how the software implements each requirement - module structure, state machine behaviour, alarm handling, data flow - and becomes the reference point that the code and the testing all trace back to. It's what your permanent team needs to maintain the system after I've gone, and it's what an auditor needs to understand the design intent.
I've worked within enough GAMP5 frameworks to understand what good validation documentation looks like and what it needs to achieve. I don't just produce deliverables that tick a box - I produce documentation that actually traces, so your validation engineers aren't left trying to reconcile what I built with what the spec says after I've left.
The test protocol should be boring. If you're discovering things during FAT/SAT, something went wrong much earlier in the project.
What you get
Structured, well-documented PLC and HMI code that fits within your validation framework. I produce software design specifications and test support documentation to the level your project requires - whether that's full GAMP5 Category 5 or something more proportionate to the risk.
The code itself is written with validation in mind from the start: standard naming conventions, clear module boundaries, version control, and a structure that makes traceability straightforward rather than retrospective. Your permanent staff can maintain it, and your quality team can audit it without needing me in the room.
I'm most often brought in to contribute controls engineering within a validation framework that's already established - either joining a project mid-lifecycle or delivering specific systems within a larger programme. I understand the documentation expectations, I know how to work alongside validation engineers and QA, and I produce deliverables that don't create problems downstream.
If I'm coming in to rescue a project that's already gone wrong - and this happens more often than it should - I'll assess what's salvageable, what needs rewriting, and what retrospective documentation is needed. I'll give you an honest view of the state of things before committing to a recovery plan.
Sectors and applications
Most of my regulated work has been in pharmaceutical manufacturing - packaging lines, process control, serialisation and track-and-trace systems. I've also delivered systems for medical device assembly, automated test equipment for in-vitro diagnostics, and process control in food and beverage where customer quality standards effectively mirror GMP requirements.
I work within established quality management systems and to client-specific SOPs. I'm not a validation consultant - I'm a controls engineer who understands what regulated environments demand and produces work accordingly. If your project needs someone who can write good code and produce documentation that doesn't fall apart under scrutiny, that's the gap I fill.