Senior Engineer, Packaging & Validation - Pharma/Med Device

Mirus Consulting Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Senior Engineer to lead engineering initiatives in manufacturing and packaging systems within a regulated pharmaceutical or medical device environment.

The successful candidate will drive projects from concept through qualification, deliver IQ/OQ/PQ protocols, and champion continuous improvement while ensuring GMP compliance and collaboration with Manufacturing, Quality, Validation, Maintenance and Operations.

Qualifications

• Engineering degree with required experience per education pathway.
• Knowledge of GMP regulations and industry standards.
• Fully bilingual in English and Spanish.

Responsibilities

• Lead and support engineering projects from concept to closure.
• Provide technical expertise in packaging equipment and troubleshooting.
• Design, specification, installation, and startup of new equipment and processes.
• Develop strategies to improve reliability, efficiency, and compliance.
• Coordinate timelines, budgets, and deliverables for projects.
• Prepare and review engineering and validation documentation (IQ/OQ/PQ).
• Ensure GMP, safety, environmental, and regulatory compliance.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, and Operations.
• Identify and implement continuous improvement opportunities in equipment and processes.
• Provide technical assessments and risk evaluations to support objectives.

Skills

packaging equipment

validation processes

GMP regulations

project management

bilingual English/Spanish

Medical Device/Pharma env

IQ/OQ/PQ

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Engineering

Job description

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Senior Engineer to lead engineering initiatives in manufacturing and packaging systems within a regulated pharmaceutical or medical device environment.

The successful candidate will drive projects from concept through qualification, deliver IQ/OQ/PQ protocols, and champion continuous improvement while ensuring GMP compliance and collaboration with Manufacturing, Quality, Validation, Maintenance and Operations.