Process validation specialist
Job in
Cincinnati, Hamilton County, Ohio, 45208, USA
Listed on 2026-07-18
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-07-18
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering, Process Engineer, Manufacturing Engineer -
Manufacturing / Production
Validation Engineer, Quality Engineering, Manufacturing Engineer
Job Description & How to Apply Below
Job Title: Senior Process Validation Engineer / Lead Validation Engineer
We are seeking an experienced Senior Process Validation Engineer / Lead Validation Engineer to lead equipment development, process characterization, validation, and manufacturing transfer activities for medical device assembly operations.
The ideal candidate should have strong expertise in:- FAT (Factory Acceptance Testing)
- Software Validation
- IQ, OQ & PQ
- MSA
- Equipment Development
- Process Validation
- Lead equipment development from concept through manufacturing handover.
- Support equipment concept creation, design reviews, approvals, build, run-off, and FAT.
- Develop and execute equipment software validation, IQ, OQ, and PQ activities.
- Review equipment requirements, specifications, safety assessments, and equipment FMEAs.
- Ensure equipment meets cycle time, capacity, cost, quality, and reliability targets.
- Provide technical leadership through production stabilization.
- Resolve equipment downtime, process variation, scrap, and supply disruptions.
- Evaluate medical device assembly technologies and supplier capabilities.
- Prepare equipment cost estimates, lead times, and capital budgets.
- Translate product requirements into equipment and assembly station requirements.
- Lead process characterization strategies for assigned equipment and processes.
- Develop process deliverables across component, assembly, and supply chain phases.
- Translate product requirements, models, FMEAs, and DFMEAs into manufacturing processes.
- Develop validation plans, protocols, reports, and acceptance criteria.
- Support manufacturing transfer and production readiness.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×