Senior Validation Engineer We are seeking a hands-on Senior Validation Engineer to lead the planning, development, execution, and lifecycle maintenance of equipment and process validation activities within a regulated manufacturing environment. This position will support manufacturing processes and equipment, lead IQ/OQ/PQ activities, collaborate with cross-functional teams, and drive continuous improvement through data-driven problem solving.
Lead validation activities for manufacturing processes, equipment, and supporting systems. Develop and execute validation documentation, including Validation Plans, URS, risk assessments, IQ/OQ/PQ protocols and reports. Coordinate shop-floor execution of validation protocols, including resources, sampling, instrumentation, and testing. Establish and evaluate critical process parameters, control limits, and process capability using DOE, MSA, SPC, and capability analysis. Analyze manufacturing and validation data to identify trends and opportunities for improvement. Lead root cause investigations, CAPA activities, and process improvement initiatives. Support equipment qualifications, process changes, equipment transfers, and engineering changes while maintaining the validated state. Partner with Manufacturing, Quality, Engineering, and other cross-functional teams on validation and process improvement activities. Support improvements to quality systems, procedures, work instructions, and validation workflows. Ensure appropriate data integrity and documentation practices within computerized systems. Bachelor's degree in Engineering, such as Mechanical, Manufacturing, Industrial, Biomedical, or a related field.
6+ years of validation experience within a regulated manufacturing environment such as medical device, pharmaceutical, or combination products.
familiarity with GAMP 5 and risk-based validation is preferred.
Strong understanding of DOE, MSA/Gage R&R, SPC, and process capability analysis.
Experience using Minitab or similar statistical software.
Strong technical writing, documentation, and data integrity skills.
Experience with process/equipment qualifications, automated manufacturing, or cleanroom environments is preferred.
Work Environment: This is an on-site position supporting manufacturing and validation activities directly on the production floor.
Senior Validation Engineer - 171296 in lake geneva at Unknown Company
This position is listed as full time and onsite.