Sr Engineer - 35800

Mirus Consulting Group

🇵🇷 Puerto Rico

Senior

4 days ago

Not enough detail in this posting to match

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 motivatedSenior 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 involvingparenteral products manufacturing,vision inspection systems,device assembly, andpackaging operations, including bothautomatic 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

Leadcommissioning, 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 forparenteralmanufacturing processes, ensuring compliance with GMP and regulatory standards.
Support implementation, startup, andoptimization of vision inspection systems used in pharmaceutical and medical device operations.
Lead engineering activities associated with deviceassembly and packaging equipment, includingautomatic 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 EngineeringOR

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

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.

Sr Engineer - 35800 · Mirus Consulting Group

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