Senior Validation Engineer

Job TitleJob Overview:Pay Range: $37.59hr - $42.59hrRequirement/Must Have:Demonstrated hands-on execution of IQ, OQ, PQ, and TMV in a medical device manufacturing environment.Proven ability to learn unfamiliar production equipment and qualify it.Working knowledge of FDA 21 CFR Part 820 and ISO 13485.Deviation investigation and root cause experience using structured methods such as 5 Why, Fishbone, or Fault Tree Analysis.Working knowledge of validation lifecycle documentation, change control, and risk management processes.Technical writing skills sufficient to produce clean, audit ready validation records.Comfort spending most of the day on a production floor with operators, engineers, and quality staff.Ability to take a defined task on a piece of equipment and complete it without daily direction.Bachelor’s degree in engineering required.Responsibilities:Execute IQ, OQ, PQ, and TMV protocols hands on, including equipment setup verification, feasibility builds, sample generation, and data capture.Own execution accuracy to ensure validation runs do not have to be repeated.Work side by side with frontline manufacturing operators throughout OQ and PQ activities.Build and compile validation documentation: protocol packets, executed records, summary reports, and supporting attachments.Investigate deviations that surface during validation execution, establish root cause, and carry corrective actions to closure.Raise and work observations that warrant investigation.Support root cause investigations on NCRs once PQ builds and commercial work orders begin.Provide manufacturing quality support after validation activities close out.Keep all validation activity aligned to FDA 21 CFR Part 820, ISO 13485, GMP, and internal QMS requirements.Nice to Have:Cardiovascular, Class III, and delivery system experience.Experience with SPC, Minitab, DOE, Gage R&R, and process capability analysis.PFMEA participation and technical drawing interpretation.Skills:IQ/OQ/PQ execution.Test Method Validation (TMV).FDA 21 CFR Part 820.ISO 13485.Root Cause Analysis (5 Why, Fishbone, Fault Tree).Technical Writing.Change Control.Risk Management.GMP.Qualification And Education:Bachelor’s degree in engineering.2+ years of relevant experience in medical device manufacturing.