Process Engineer I: Validation & Process Optimization

Quality Consulting Group, LLC; Humacao (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico and the USA, contributing to process validation and equipment qualification in a world-class manufacturing environment.

The role requires a Bachelor's in engineering and 3+ years in validation, with flexibility for first and/or second shift. You will support PV/CSV activities, drive process improvements, and ensure compliance with regulations.

Qualifications

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

Responsibilities

• Generate, execute process validation plan and reports (PV: characterization, OQ, PQ) and equipment qualification (CSV: URS, FAT, IQ, OQ, PQ, TMV).
• 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.

Skills

3+ years validation experience

Shift availability

Education

Bachelor's degree in Mechanical, Biomedical, Industrial or Chemical Engineering

Job description

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico and the USA, contributing to process validation and equipment qualification in a world-class manufacturing environment.

The role requires a Bachelor's in engineering and 3+ years in validation, with flexibility for first and/or second shift. You will support PV/CSV activities, drive process improvements, and ensure compliance with regulations.