mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.
Position Summary
The Principal Engineer provides senior-level technical leadership in the design, operation, and improvement of critical utility systems within a regulated GMP environment. This role is responsible for ensuring the reliability, compliance, and continuous improvement of clean utilities and clean gas systems while supporting critical operations and capital projects. The Principal Engineer serves as a technical expert, mentor, and key contributor to deviation management, documentation, and SOP optimization.
Key Responsibilities
Technical Leadership & Engineering Support
- Provide subject matter expertise (SME) for clean utility systems, including Distilled Water (DW), Purified Water (PW), Reverse Osmosis (RO), and related distribution systems.
- Support engineering activities related to clean and GMP utility gases, such as Process Air, Oxygen, Nitrogen, and other regulated gas supply systems.
- Lead or support troubleshooting of critical utility systems or manufacturing operations to ensure operational reliability, safety, and regulatory compliance.Prin
GMP
- Author, review, and approve GMP documentation, including SOPs, engineering protocols, reports, and technical assessments.
- Ensure engineering activities comply with GMP, FDA, and internal quality standards.
- Drive continuous improvement initiatives focused on process robustness, compliance, and documentation excellence.
Capital Projects & Operational Excellence
- Actively participate in or lead capital projects, including scope definition, system design review, installation, commissioning, and qualification support.
- Collaborate cross-functionally with Operations, Quality, Validation, Maintenance, and Project Management teams.
- Provide risk assessments and technical input for system upgrades, expansions, and lifecycle management.
Mentorship & Knowledge Sharing
- Serve as a technical mentor for junior and mid-level engineers.
- Promote engineering standards, best practices, and knowledge sharing across the organization.
Qualifications
- Doctorate (PhD) in Engineering with 2+ years of engineering experience, OR
- Master’s degree in Engineering with 4+ years of engineering experience, OR
- Bachelor’s degree in Engineering with 6+ years of engineering experienc
Degree in Mechanical Engineering or Chemical Engineering.
Technical & Professional Requirements
- Demonstrated experience working with Clean Utility Systems (DW, PW, RO).
- Hands-on experience supporting or managing clean gas and GMP utility systems (Process Air, Oxygen, Nitrogen, etc.).
- Proven experience documenting and managing deviations (non-conformances) in regulated environments.
- Strong proficiency in GMP documentation, including SOP creation, review, and process improvement.
- Experience working in critical operations and capital project environments.
- Strong analytical, problem-solving, and decision-making skills.
- Ability to communicate effectively across technical and non-technical stakeholders.
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.