Sr Engineer - 35627

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 is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

We are seeking a highly motivated Senior Engineer to support engineering initiatives related to manufacturing, packaging systems, equipment design, validation activities, and capital projects within a regulated pharmaceutical or medical device environment. The successful candidate will lead and support engineering projects, ensure compliance with quality and regulatory requirements, and drive continuous improvement efforts to optimize operational performance.

Key Responsibilities

• Lead and support engineering projects from concept, design, implementation, qualification, and closure.
• Provide technical expertise in packaging equipment, including troubleshooting, optimization, and lifecycle management.
• Support the design, specification, installation, and startup of new equipment and manufacturing processes.
• Develop and execute engineering strategies to improve reliability, efficiency, and compliance.
• Coordinate and manage project activities, timelines, budgets, and deliverables.
• Author, review, and approve engineering and validation documentation, including protocols and reports.
• Ensure compliance with applicable GMP, safety, environmental, and regulatory requirements.
• Collaborate with cross-functional teams including Manufacturing, Quality, Validation, Maintenance, and Operations.
• Identify and implement continuous improvement opportunities related to equipment performance and process efficiency.
• Provide technical assessments, risk evaluations, and engineering solutions to support business objectives.

Qualifications

Candidates must meet one of the following education and experience requirements:

• Doctorate degree in Engineering; OR
• Master's degree in Engineering and two (2) years of engineering experience; OR
• Bachelor's degree in Engineering and four (4) years of engineering experience.
  • Bachelor's degree in Engineering and five (5) or more years of engineering experience.
• Strong knowledge of packaging equipment and manufacturing systems.
• Experience in the design and implementation of new equipment and process technologies.
• Experience managing engineering projects.
• Knowledge of equipment qualification and validation processes (IQ/OQ/PQ).
• Experience working in Medical Device and/or Pharmaceutical manufacturing environments.
• Knowledge of GMP regulations and industry standards.
• Strong problem-solving, analytical, and project management skills.
• Excellent verbal and written communication skills.
• Fully bilingual in English and Spanish.

Shift:

8:00 AM – 5:00 PM

Work Schedule:

Overtime may be required based on business needs.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.