Hire a Fractional Automation Engineer for Medical Device Equipment
A fractional automation engineer works for your company on a project basis — during equipment procurement, specification, validation, and qualification — without the overhead of a full-time hire. For IVD manufacturers and consumable diagnostic companies doing 1–3 capital equipment installations per year, the fractional model typically costs 40%–60% less than a full-time senior automation engineer and eliminates the recruiting and ramp-up time.
Most IVD manufacturers and consumable diagnostic companies don’t need a full-time senior automation engineer.
They need one for a capital equipment project. They need the GAMP documentation done right. They need the URS written before the RFQ goes out, the FAT attended, the IQ/OQ/PQ protocols executed, and the SOPs drafted. Then the project wraps up and the need is gone until the next installation.
But the full-time senior automation engineer is there every week, at $130,000–$162,000 in base salary, whether there’s a capital project running or not. That math doesn’t work for most mid-sized IVD companies.
MEPSCo GAMP is built specifically for this situation. Reza Bashar brings 25+ years of automation engineering experience in medical device manufacturing to each engagement — working exclusively on the manufacturer’s side, never for a vendor — and has completed GAMP documentation packages for 96+ equipment installations.
If you have a capital equipment project coming up and want to talk through scope, schedule a project review.
What a Fractional Automation Engineer Does
Fractional doesn’t mean partial attention. It means you pay for the engineering time you actually need, during the project phases that require it — not between projects.
CRD and URS Development
Defining what the equipment needs to do before any vendor conversation happens. This is the work that prevents change orders and ensures the vendor quotes to your requirements, not their assumptions. More on URS development.
Vendor Evaluation and RFQ Support
Reviewing vendor proposals against the URS. Running the technical review. Helping you compare bids that aren’t apples-to-apples because the specs aren’t identical.
Factory Acceptance Testing (FAT)
Attending the FAT at the vendor’s facility, running the protocol, and documenting the results. If the equipment doesn’t pass, the issues get resolved at the vendor’s site — before the equipment ships, before installation costs are committed.
SAT and IQ/OQ/PQ
Once the equipment is at your facility, executing the qualification sequence. Writing the protocols, running the tests, completing the documentation package that goes into your quality system.
SOP Development
Writing the operating procedures that reflect how the equipment actually runs in your validated configuration — not a template.
Sustaining Support
Change control, requalification after equipment modification, and ongoing documentation updates as the process evolves.
The engagement is project-scoped. You define what phases you need support on. MEPSCo GAMP scopes the hours, not an open-ended retainer.
What It Costs vs. a Full-Time Hire
A senior automation engineer in life sciences runs $130,000–$162,000 in base salary per KORE1’s 2026 Automation Engineer Salary Guide. Add employer benefits, payroll taxes, and overhead, and the first-year total cost of a full-time senior automation engineer runs $230,000–$280,000 — before recruiting fees, which typically run 15%–25% of first-year salary.
A fractional automation engineer engagement for a single capital equipment installation runs 121–250 hours at $150–$275/hr, depending on equipment complexity and project scope. That puts per-project cost at roughly $21,000–$56,000.
For a company doing one or two equipment installations per year, the math is simple. Two full fractional engagements in a year cost roughly $42,000–$112,000. A full-time senior automation engineer costs $230,000–$280,000 — before the recruiting investment to find one.
The full-time model makes sense for companies running 4–6+ concurrent equipment projects or maintaining a large installed base that requires constant sustaining engineering support. Below that threshold, fractional is almost always the more cost-effective structure.
Read more in the fractional vs. full-time automation engineer cost comparison.
Why Manufacturer-Side Matters
Most automation engineers who support medical device equipment projects come from one of two directions: vendor-side (working for the equipment manufacturer) or validation-side (working from the QA template outward).
MEPSCo GAMP works from neither direction. Reza’s background is in automation engineering and equipment procurement — understanding what equipment needs to do, how to specify it, and how to hold vendors accountable for what they quoted. That’s a different vantage point than a validation consultant who knows the IQ/OQ/PQ protocol structure but hasn’t sat in a vendor’s shop running a FAT.
Manufacturer-side means no vendor relationship, no integration commission, and no incentive to specify a particular vendor’s equipment. The URS reflects your requirements. The FAT protocol is written to catch gaps, not to pass everything and move on.
Who This Is Built For
MEPSCo GAMP’s fractional engagement model is built for:
This isn’t right for catheter companies or implantable device manufacturers — the GAMP process for capital production equipment in consumable diagnostics is specifically what MEPSCo GAMP is built around.
Not Right For Everyone
If you’re buying standard commercial-off-the-shelf equipment with no customization and no qualification requirement, you don’t need fractional automation engineering support. Some equipment comes with a full IQ/OQ/PQ package from the vendor. If yours does, and the package meets your quality system requirements, the documentation work is largely done.
The engagement makes sense when:
How an Engagement Starts
A first conversation is a scope review. Bring the equipment type, the project timeline, the regulatory context, and what documentation you already have. MEPSCo GAMP will tell you what’s missing, what the scope of support looks like, and what a realistic timeline from CRD to validated production looks like for your project.
Most engagements start before the RFQ is issued — that’s when the CRD and URS work happens. But MEPSCo GAMP also takes on engagements mid-project where the documentation is behind schedule or the change orders have started and the gap needs to be assessed.
Common Questions on Hiring a Fractional Automation Engineer
What does a fractional automation engineer do that a validation consultant doesn’t?
A validation consultant typically works from the quality system outward — knowing the IQ/OQ/PQ protocol structure and ensuring it satisfies regulatory requirements. A fractional automation engineer works from the equipment requirement inward — defining what the equipment needs to do, holding the vendor to it during FAT, and then confirming it during qualification. The MEPSCo GAMP engagement covers both: the specification and procurement phases that prevent problems, and the qualification phases that document the outcome.
How long does a fractional automation engineering engagement typically run?
A typical engagement from CRD and URS through IQ/OQ/PQ completion runs 4–9 months for a single piece of capital equipment, depending on equipment complexity, vendor build lead time, and your facility’s readiness. The engineering hours aren’t continuous — there are active phases (URS development, FAT, IQ/OQ/PQ execution) and waiting periods (vendor build time, installation). You’re billed for active project work, not calendar time.
Can you engage MEPSCo GAMP after the equipment is already ordered?
Yes. Mid-project engagements are common — especially when the URS wasn’t complete before the vendor was selected, change orders have started, or the qualification documentation is behind schedule. The starting point is a review of what’s been specified, what’s been changed, and what the qualification path looks like given the current project state. The earlier in a project MEPSCo GAMP gets involved, the less expensive the fix — but the engagement is available at any phase.
Does MEPSCo GAMP work with a specific list of equipment vendors?
No. MEPSCo GAMP is vendor-neutral by design. The URS defines your requirements; the vendor evaluation assesses who can meet them. Reza has worked with a range of automation vendors across IVD and consumable diagnostic equipment — fill systems, assembly automation, test and inspection equipment — but there are no vendor relationships that would bias the specification or the vendor selection. Manufacturer-side means manufacturer-side.
What happens if the equipment fails FAT?
A FAT failure is the right outcome when the equipment doesn’t meet the URS. The FAT is designed to catch qualification gaps before the equipment ships — when it’s least expensive to fix them. MEPSCo GAMP’s FAT attendance is specifically to run the protocol rigorously, document any deviations, and work with the vendor to resolve open items before the equipment leaves their facility. A passed FAT with open items documented as deviations is better than a failed IQ/OQ/PQ at your site six months later.
Related Pages
Fractional Automation Engineer
The service hub: the full equipment procurement lifecycle, or any part of it.
READ MORE →Fractional vs. Full-Time: The Cost Breakdown
Year-one cost, line by line, for IVD manufacturers.
READ MORE →Fractional vs. Full-Time Hire
When each model wins the math.
READ MORE →Fractional vs. Validation Consulting Firm
One engineer with a process, versus a deployed team.
READ MORE →GAMP Documentation Services
22 document types and the 8-step process.
READ MORE →CDMO Automation Procurement
Equipment engineering for contract diagnostic manufacturers.
READ MORE →Every Week Unqualified Is a Week of Delayed Production
Every week a capital equipment project sits unqualified is a week of delayed production release. Schedule a project review with MEPSCo GAMP — tell us what you’re procuring and when you need it validated.