Senior Engineer — Pharma Manufacturing & Process Improvement

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 95,000 - 135,000; Full time

Job summary

Quality Consulting Group, LLC is a leading firm serving the pharmaceutical, biotech, medical devices, and manufacturing sectors in Puerto Rico and the USA. We seek an experienced engineer to lead process optimization, troubleshoot operations, and collaborate across departments in a regulated manufacturing environment.

The candidate will develop design documents, support deviations and CAPAs, and review technical reports and equipment qualifications.

Qualifications

• Bachelor’s degree in Engineering is required.
• Proven experience performing technical assessments of equipment in regulated pharmaceutical, biotechnology, or manufacturing environments.
• Experience preparing, reviewing, and approving technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Strong knowledge of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.

Responsibilities

• Independently assesses and directs characterization of process optimization strategies and troubleshooting in manufacturing environments.
• Collaborates with research, manufacturing, process development, utilities, facilities, QA and validation for complex system/facility modifications.
• Works with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
• Coordinates consultants, architects and engineering firms on standard design documents.
• Develops departmental or project budgets across multiple disciplines within a project.

Skills

Technical writing

Cross-functional

Regulatory compliance

Root cause analysis

Equipment qualification

Troubleshooting

Quality documentation

Process engineering

Project coordination

Risk assessment

cGMP awareness

Quality systems

Education

Bachelor’s degree in Engineering

Job description

Quality Consulting Group, LLC is a leading firm serving the pharmaceutical, biotech, medical devices, and manufacturing sectors in Puerto Rico and the USA. We seek an experienced engineer to lead process optimization, troubleshoot operations, and collaborate across departments in a regulated manufacturing environment.

The candidate will develop design documents, support deviations and CAPAs, and review technical reports and equipment qualifications.