Sr Engineer

mîrus Consulting Group View all jobs

Juncos, PR
Permanent
Full-time

23 days ago

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 Senior Engineer provides technical leadership and engineering support for manufacturing operations, with strong emphasis on aseptic processing and Fill/Finish environments. This role plays a key part in supporting New Product Introduction (NPI) activities, equipment characterization, and performance qualification (PQ), ensuring robust, compliant, and efficient manufacturing processes. The Senior Engineer applies advanced engineering knowledge to drive technical problem solving, process optimization, and successful implementation of new products and technologies, while ensuring compliance with GMP and regulatory requirements.Key Responsibilities

Provide engineering expertise to support aseptic processing operations, including Fill/Finish systems such as vial and syringe filling lines.
Lead and support characterization studies and Performance Qualification (PQ) activities for New Product Introductions (NPI).
Serve as a technical lead for equipment, process improvements, and troubleshooting in manufacturing environments.
Support the installation, commissioning, qualification, and validation of new and existing equipment.
Collaborate cross‑functionally with Manufacturing, Quality, Validation, Automation, and Technical Operations teams.
Ensure engineering activities comply with GMP requirements, internal procedures, and regulatory expectations.
Develop and review technical documentation including protocols, reports, and engineering assessments.
Drive continuous improvement initiatives to enhance process performance, efficiency, and reliability.
Provide technical support during audits, inspections, and regulatory interactions as needed.
Mentor junior engineers and contribute to knowledge sharing and engineering best practices.

Requirements

Doctorate degree in Engineering, or
Master’s degree in Engineering with a minimum of 2 years of relevant engineering experience, or
Bachelor’s degree in Engineering with a minimum of 4 years of relevant engineering experience
Field of Study: Mechanical or Chemical Engineering discipline.
Experience within pharmaceutical, biotechnology, or regulated manufacturing environments.
Strong background in aseptic processing and Fill/Finish operations.
Demonstrated experience supporting NPI, characterization, and PQ activities.

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.

mîrus Consulting Group

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