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Sr Engineer -35710
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
The Senior Engineer will provide technical and operational support for manufacturing and process improvement initiatives within a regulated environment. This role is responsible for leveraging engineering principles, data analytics, digital solutions, and continuous improvement methodologies to enhance manufacturing performance, operational efficiency, and compliance. The ideal candidate is a self-driven professional who can navigate ambiguous business needs and translate operational challenges into practical digital tools, dashboards, and sustainable process improvements.
Key Responsibilities
• Analyze manufacturing and operational data to identify trends, opportunities, and improvement initiatives.
• Design, develop, and maintain dashboards, reports, and digital tools that support business and manufacturing objectives.
• Support process improvement projects through data-driven analysis and engineering solutions.
• Generate and maintain GMP-compliant documentation and support validation-related activities as required.
• Collaborate with cross-functional teams to support manufacturing operations, engineering studies, process characterization, PPQ activities, and manufacturing readiness efforts.
• Utilize automation and digital technologies to improve efficiency, reduce manual processes, and enhance operational effectiveness.
• Translate complex operational challenges into practical and scalable technical solutions.
• Support continuous improvement initiatives to drive operational performance, compliance, and reliability.
• Communicate technical findings, recommendations, and project progress to stakeholders and leadership.
Minimum Qualifications
Preferred Qualifications
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.
Position Summary
The Senior Engineer will provide technical and operational support for manufacturing and process improvement initiatives within a regulated environment. This role is responsible for leveraging engineering principles, data analytics, digital solutions, and continuous improvement methodologies to enhance manufacturing performance, operational efficiency, and compliance. The ideal candidate is a self-driven professional who can navigate ambiguous business needs and translate operational challenges into practical digital tools, dashboards, and sustainable process improvements.
Key Responsibilities
• Analyze manufacturing and operational data to identify trends, opportunities, and improvement initiatives.
• Design, develop, and maintain dashboards, reports, and digital tools that support business and manufacturing objectives.
• Support process improvement projects through data-driven analysis and engineering solutions.
• Generate and maintain GMP-compliant documentation and support validation-related activities as required.
• Collaborate with cross-functional teams to support manufacturing operations, engineering studies, process characterization, PPQ activities, and manufacturing readiness efforts.
• Utilize automation and digital technologies to improve efficiency, reduce manual processes, and enhance operational effectiveness.
• Translate complex operational challenges into practical and scalable technical solutions.
• Support continuous improvement initiatives to drive operational performance, compliance, and reliability.
• Communicate technical findings, recommendations, and project progress to stakeholders and leadership.
Minimum Qualifications
- Doctorate Degree in Engineering; OR
- Master's Degree in Engineering plus two (2) years of engineering experience; OR
- Bachelor's Degree in Engineering plus four (4) years of engineering experience.
Preferred Qualifications
- Experience with data analysis, visualization tools, and dashboard development.
- Knowledge of statistical evaluation and data-driven decision-making.
- Experience authoring and supporting GMP documentation.
- Understanding of validation principles and process improvement methodologies.
- Experience with AI-enabled, automation, or digitalization tools such as Python, Codex, Power Automate, SQL, and/or VBA.
- Experience supporting Drug Product manufacturing operations.
- Exposure to characterization studies, engineering runs, process performance qualification (PPQ), validation activities, and manufacturing readiness initiatives.
- Ability to identify opportunities for operational excellence and implement sustainable solutions.
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.