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.
Role Summary The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.
Key Responsibilities
Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
Design and develop in‑process and receiving inspection systems for new components and processes.
Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
Manage process development projects from concept through implementation, collaborating with cross-functional teams.
Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.
Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).
Experience Requirements
5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).
Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.
Electrical and mechanical engineering background applied to automated manufacturing systems.
Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.
Proficiency in DOE, FMEA, CAPA, and root‑cause investigation.
Experience supporting new product introductions and process scale‑up.
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.