Sr Engineer - 35800

Mirus Consulting Group; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico seeks a Senior Engineer to support commissioning, qualification, and lifecycle management 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 automatic and High-Mix Low-Volume production lines.

Qualifications

• Doctorate or Master's/Bachelor's with engineering experience in regulated environments.
• Experience with equipment qualification, validation, and manufacturing processes.
• Strong knowledge of GMP and regulatory standards.

Responsibilities

• Lead commissioning, qualification, and validation for manufacturing equipment and systems.
• Develop, execute, and approve IQ/OQ/PQ protocols and related docs.
• Support parenteral manufacturing processes ensuring GMP compliance.
• Assist start-up and optimization of vision inspection systems in pharma/medical device ops.
• Lead device assembly and packaging equipment, including automatic and HMLV lines.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, and Regulatory Affairs.
• Support investigations, change controls, CAPAs, deviations, and risk assessments.
• Evaluate equipment performance and identify process improvements and efficiency gains.
• Ensure activities meet safety, quality, and compliance requirements.

Skills

GMP knowledge

Engineering leadership

Commissioning

Qualification protocols (IQ/OQ/PQ)

Parenteral manufacturing

Vision inspection systems

Education

Doctorate in Engineering

Master's Degree in Engineering + 2 years experience

Bachelor's Degree in Engineering + 4 years 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.