JT647 - PROCESS ENGINEER I

Quality Consulting Group, LLC is a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry. They are seeking a Process Engineer I to generate and execute process validation plans, provide technical support, and lead innovation in manufacturing processes. The role focuses on improving production efficiencies and ensuring compliance with regulations in a manufacturing environment.

Responsibilities:

• Generate, execute process validation plan and reports [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
• Provides technical and sustaining engineering support in a manufacturing area
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products
• Integrates equipment and material capabilities to meet process module target specifications and technology target specifications
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules
• Interacts with product design and development personnel to ensure that processes and designs are compatible
• May develop and conduct statistical analysis or recommend additions to document work
• Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations
• This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems
• Ensures processes and procedures are in compliance with regulations

Requirements:

• Bachelor's degree in Mechanical, Biomedical, Industrial or Chemical Engineering
• 3+ years in validation experience
• Availability to work first and / or second shift (If require) mainly first shift