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 Engineer supports manufacturing operations for fermentation, cell culture, and harvest processes to ensure safe, compliant, and efficient execution of commercial and development manufacturing campaigns. This role focuses on process performance, technical troubleshooting, documentation, and cross‑functional collaboration to maintain robust, reproducible, and compliant biopharmaceutical manufacturing operations under cGMP regulations. The Engineer provides technical support on the manufacturing floor, contributes to continuous improvement initiatives, and supports process monitoring, investigations, and documentation activities while ensuring adherence to internal procedures, regulatory expectations, and business objectives.
Key Responsibilities
Provide day‑to‑day engineering and technical support to Fermentation, Cell Culture, and Harvest manufacturing operations.
Support execution of commercial manufacturing campaigns, ensuring process consistency, product quality, and schedule adherence.
Monitor and evaluate process performance, including critical process parameters, trends, and deviations.
Support troubleshooting of manufacturing issues and participate in root cause investigations and corrective actions.
Author, review, and maintain manufacturing and engineering documentation, including procedures, batch records, technical reports, and change controls.
Support implementation of process improvements to enhance efficiency, robustness, and compliance.
Collaborate closely with Manufacturing, Quality, Process Development, Automation, and Engineering teams.
Support new process introductions, scale‑up activities, and technology transfers as required.
Ensure compliance with cGMP, safety standards, and company policies during all manufacturing activities.
Support validation, qualification, and continued process verification activities as applicable.
Participate in regulatory inspections, audits, and internal assessments by providing technical expertise and documentation support.
Support extended coverage or flexible schedules based on manufacturing and business needs.
Education & Experience Requirements One of the following is required:
Master’s degree in Engineering or related scientific discipline OR
Bachelor’s degree in Engineering with a minimum of 2 years of engineering experience in a pharmaceutical, biopharmaceutical, or biotechnology manufacturing environment.
Preferred Experience & Knowledge Hands‑on experience or strong technical knowledge in one or more of the following:
Fermentation
Cell Culture
Harvest operations
Experience supporting commercial manufacturing campaigns. Familiarity with large‑scale bioprocessing equipment and operations. Understanding of biological upstream and downstream interfaces.
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.