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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 engineering initiatives within a regulated manufacturing environment. This individual will be responsible for leading equipment and process-related projects, supporting new equipment design and implementation, executing validation activities, and driving engineering solutions that improve operational performance, quality, and compliance.
The ideal candidate will possess strong technical expertise in packaging equipment, engineering project management, equipment design, and validation processes. This role requires collaboration across multiple functions to ensure engineering projects are delivered safely, efficiently, and in compliance with applicable regulatory requirements.
Key Responsibilities
Minimum Education & Experience
Shift: First Shift (8:00 AM – 5:00 PM)
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
We are seeking a highly motivated Senior Engineer to support engineering initiatives within a regulated manufacturing environment. This individual will be responsible for leading equipment and process-related projects, supporting new equipment design and implementation, executing validation activities, and driving engineering solutions that improve operational performance, quality, and compliance.
The ideal candidate will possess strong technical expertise in packaging equipment, engineering project management, equipment design, and validation processes. This role requires collaboration across multiple functions to ensure engineering projects are delivered safely, efficiently, and in compliance with applicable regulatory requirements.
Key Responsibilities
- Lead engineering projects from concept through implementation and operational readiness.
- Support the design, specification, installation, and startup of new manufacturing and packaging equipment.
- Knowledge in Design of new equipment process.
- Develop engineering solutions to improve equipment reliability, efficiency, and performance.
- Manage project timelines, budgets, resources, and deliverables.
- Coordinate cross-functional project activities with Operations, Quality, Validation, Maintenance, and Manufacturing teams.
- Plan and execute equipment qualification and validation activities, including IQ, OQ, and PQ protocols.
- Ensure compliance with cGMP, quality standards, and applicable regulatory requirements.
- Generate and review engineering documentation, technical reports, specifications, protocols, and change control records.
- Support new product introductions and process optimization efforts.
- Collaborate with vendors, contractors, and external partners as required.
Minimum Education & Experience
- 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.
- Knowledge of packaging equipment and packaging operations.
- Experience with the design and implementation of new equipment and manufacturing processes.
- Knowledge of engineering project management principles and execution.
- Experience supporting equipment and validation process activities.
- Experience within the Medical Device and/or Pharmaceutical industry.
- Strong problem-solving and analytical skills.
- Excellent technical writing and documentation skills.
- Ability to work effectively in a cross-functional team environment.
- Fully bilingual in English and Spanish (written and verbal).
Shift: First Shift (8:00 AM – 5:00 PM)
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