Senior Process Engineer: Machine Vision & Validation

Pinnaql; Nicholasville (KY); Presencial; USD 90.000 - 130.000; Tempo integral

Resumo da vaga

Pinnaql is seeking an experienced Senior Process Engineer to independently drive deliverables in manufacturing process characterization, machine vision implementation, equipment qualification, process validation, and GMP documentation at a client site in Nicholasville, KY. This onsite role will support multiple strategic projects within regulated environments.

The role requires strong technical writing, cross-functional collaboration, and a proven track record in FDA-regulated manufacturing

Qualificações

• Minimum 5 years of Process Engineering, Machine Vision, Validation, or related experience.
• Experience in FDA-regulated medical device or pharmaceutical environments.
• Experience with machine vision and learning for process characterization and validation.
• Experience supporting equipment qualifications and system verification activities.
• Strong GMP documentation practices and technical writing skills.

Responsabilidades

• Independently execute and drive deliverables for manufacturing process characterization.
• Lead machine vision implementation and AI-based inspection initiatives.
• Qualification and validation activities including IQ/OQ/PQ protocols.
• Develop technical documentation and validation reports for regulated systems.
• Support continuous manufacturing improvements and cross-functional teams.

Conhecimentos

Process Engineering

Machine Vision

Process Validation

Technical Documentation

Continuous Manufacturing

Ferramentas

Machine Vision Systems

AI/ML for image analysis

Descrição da vaga

Pinnaql is seeking an experienced Senior Process Engineer to independently drive deliverables in manufacturing process characterization, machine vision implementation, equipment qualification, process validation, and GMP documentation at a client site in Nicholasville, KY. This onsite role will support multiple strategic projects within regulated environments.

The role requires strong technical writing, cross-functional collaboration, and a proven track record in FDA-regulated manufacturing