Process Engineer I: Validation & Process Optimization

qualityconsultinggroup; Humacao (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, seeks a motivated professional to join our team in Puerto Rico & USA. Responsibilities include generating and executing PV plans and equipment qualifications, providing technical engineering support, and driving process improvements for manufacturing operations.

The role involves collaboration with design and development, leading new manufacturing concepts, and ensuring regulatory

Qualifications

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

Responsibilities

• Generate, execute process validation plans and reports (PV: characterization, OQ, PQ) and equipment qualification (CSV: URS, FAT, IQ, OQ, PQ, TMV).
• Provide technical and sustaining engineering support in a manufacturing area.
• Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, yields.
• Integrate equipment and material capabilities to meet process module target specifications and technology targets.
• Review product development requirements for compatibility with processing methods to determine costs and schedules.
• Interact with product design and development personnel to ensure processes and designs are compatible.
• Lead the innovation, development and optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
• Develop manufacturing processes applicable to statistical process control and related measurement systems.
• Ensure processes and procedures are in compliance with regulations.

Skills

Validation experience

Shift flexibility

Education

Bachelor's degree in Mechanical Engineering

Job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, seeks a motivated professional to join our team in Puerto Rico & USA. Responsibilities include generating and executing PV plans and equipment qualifications, providing technical engineering support, and driving process improvements for manufacturing operations.

The role involves collaboration with design and development, leading new manufacturing concepts, and ensuring regulatory