Sr Engineer - 35800

Mirus Consulting Group; Juncos (PR); On-site; USD 110,000 - 150,000; Full time

Job summary

mîrus Consulting Group is a local firm in Humacao, Puerto Rico offering validation and IT consulting for pharmaceutical clients. We seek a Senior Engineer to lead commissioning, qualification, and lifecycle activities for manufacturing equipment and systems within a regulated pharma environment.

The role requires expertise in parenteral processes, vision inspection systems, device assembly and packaging, including automatic and HMLV production lines, to ensure compliance and reliable product

Qualifications

• Doctoral, master’s, or bachelor’s degree in Engineering with required years of experience.

Responsibilities

• Lead commissioning, qualification, and validation activities for manufacturing equipment, utilities, and automated systems.
• Develop, execute, and approve IQ, OQ, PQ protocols and related documentation.
• Provide engineering support for parenteral manufacturing processes ensuring GMP compliance.
• Support implementation, startup, and optimization of vision inspection systems in pharma/medical device operations.
• Lead engineering activities for device assembly and packaging equipment, including automatic and HMLV lines.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, and Regulatory Affairs for project execution.
• Support investigations, change controls, CAPAs, deviations, and risk assessments related to equipment and processes.
• Evaluate equipment performance and identify opportunities for process improvements and efficiency.
• Ensure activities adhere to safety, quality, and compliance requirements.

Education

Doctorate Degree in Engineering

Master's Degree in Engineering and 2 years of Engineering experience

Bachelor's Degree in Engineering and 4 years of Engineering experience

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 commissioning, qualification, and lifecycle management activities for manufacturing equipment and systems within a regulated pharmaceutical environment. The successful candidate will provide technical leadership for projects involving parenteral products manufacturing, vision inspection systems, device assembly, and packaging operations, including both automatic and High-Mix Low-Volume (HMLV) production lines. This role requires strong technical expertise in equipment qualification, validation, and manufacturing processes to ensure compliance with regulatory requirements, operational excellence, and reliable product supply.

Key Responsibilities

• Lead commissioning, qualification, and validation activities for manufacturing equipment, utilities, and automated systems.
• Develop, execute, and approve qualification protocols including IQ, OQ, PQ, and associated documentation.
• Provide engineering support for parenteral manufacturing processes, ensuring compliance with GMP and regulatory standards.
• Support implementation, startup, and optimization of vision inspection systems used in pharmaceutical and medical device operations.
• Lead engineering activities associated with device assembly and packaging equipment, including automatic and HMLV production lines.
• Collaborate with cross-functional teams including Manufacturing, Quality, Validation, Maintenance, and Regulatory Affairs to ensure successful project execution.
• Support investigations, change controls, CAPAs, deviations, and risk assessments related to equipment and manufacturing processes.
• Evaluate equipment performance and identify opportunities for process improvements, reliability enhancements, and operational efficiency.
• Ensure engineering activities are executed in accordance with safety, quality, and compliance requirements.

Education

• Doctorate Degree in Engineering OR
• Master's Degree in Engineering and 2 years of Engineering experience OR
• Bachelor's Degree in Engineering and 4 years of Engineering experience

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.