We are seeking an experienced
Senior Process Engineer capable of independently executing and driving deliverables related to manufacturing process characterization, machine vision implementation, equipment qualification, process validation, technical documentation, and continuous manufacturing support within a regulated environment. This in an onsite position at a client site in Nicholasville, KY and will support multiple strategic projects and manufacturing initiatives.
Description:- Process Engineering & Manufacturing Support
- Characterize process capability, assess Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs), and evaluate controls
- Engineering studies/DOE to support process improvements and manufacturing objectives
- Root cause investigations and implementation of corrective actions Cross-functional collaboration with Manufacturing, Operations, Engineering, Maintenance, and Quality teams
- Machine Vision & Artificial Intelligence Machine vision system development and deployment for dimensional inspection and defect detection
- Application of AI and machine learning for image classification, anomaly detection, and process monitoring
- Camera, lighting, optics, and image-processing optimization
- Engineering studies to establish system capability, reliability, and inspection limits Qualification and validation of machine vision and AI-based inspection systems Qualification & Validation
- Support Development and execution of IQ, OQ, and PQ protocols Equipment qualification for new and existing systems
- Process validation planning, execution, and reporting Management of protocol deviations, exceptions, and associated investigations
- Change control assessments and implementation support Development of validation summary reports and final project deliverables
- GMP Documentation Development - Author, revise, and support approval of documentation including: Technical documentation, risk assessment, and change control support
- Process Evaluation Reports Process Characterization Protocols and Reports P
- rocess Validation Protocols and Reports
- Equipment Qualification Documentation
- User Requirements and supporting qualification documentation as required
Qualifications:- Minimum 5 years of Process Engineering, Machine Vision, Validation, Manufacturing Engineering, or related experience
- Experience within Medical Device, IVD, Diagnostics, Biotechnology, Pharmaceutical, or other FDA-regulated manufacturing environments
- Demonstrated experience with Machine Vision and Learning Experience performing process characterization and process validation activities
- Experience supporting equipment qualifications and system verification activities
- Strong understanding of GMP requirements and regulated documentation practices
- Strong technical writing and documentation skills
- Ability to independently drive project deliverables and interact effectively across multiple functional groups
