Duration: 6 months to start
Hours per week: 40 (potential OT from time to time)
Start Date: Immediate
Job Description:
Our client is currently seeking 2-3 Validation Engineers to assist with general validation engineering activities for a nonsterile API facility. General functions would include equipment validation, execution work, working on core validations, SOP’s, technical writing, visual inspections for cleaning validations, and authoring deviation reports. There are templates in place associated with protocol writing, and equipment descriptions can be copied/pasted, but most focus would be working directly on rationales (how & why they approach validation this way, etc.). Additionally, resources will be assisting with IQ/OQ/PQ’s, sampling processes, CAPA closures, lab equipment, utilities, validating equipment, and testing out IQ/OQ/PQ’s.
Will be extremely helpful if candidates carry any experience with temp mapping, automation, or periodic review systems/activities experience as there will be more of a workload that can be taken on. The facility is a 24/7 facility and there may be weekends that resources will need to be flexible for last minute executions. Work weeks will average 40 hours per week with preferred flexibility to work fluid days to accommodate last minute executions or average 40 hours work weeks.
Skills required:
Validation engineering, GMP, documentation techniques, investigation skills (authoring deviation reports / validation protocols), cleaning validation, SOP’s, and nonsterile API’s.
Validation Engineers (2-3 Spots) (232799) Dallas, TX – 100% onsite
