Validation Engineer

mîrus Consulting Group is a Puerto Rico–based consulting firm headquartered in Humacao, specializing in Computer System Validation (CSV), Information Technology, and Engineering services for the pharmaceutical and biotechnology industries. The company provides expertise in the assessment, validation, and optimization of automation systems, network infrastructures, and business processes, as well as full project management support across Puerto Rico and United States

Job Summary:

The Project Engineer/Validation Engineer is responsible for planning, executing, and overseeing engineering projects from concept to completion. This role involves designing, coordinating, and implementing operational plans that ensure the successful installation, testing, and qualification of equipment, tooling, and manufacturing processes. The Project Engineer works independently or under limited supervision on complex assignments that require technical expertise, sound judgment, and leadership to meet defined timelines and project objectives.

Key Responsibilities:

• Develop, communicate, and execute project plans, designs, and schedules to support new equipment installations, process transfers, and validation activities.
• Perform process and equipment validations to ensure compliance with GMP and quality standards.
• Identify non-conformances and lead investigations, including root cause analysis and implementation of corrective and preventive actions (CAPA).
• Provide technical guidance to technicians and ensure all work adheres to site-specific safety, regulatory, and environmental requirements.
• Monitor project progress, manage deliverables, and ensure alignment with customer and operational goals.
• Collaborate with cross-functional teams (Quality, Operations, and Engineering) to resolve manufacturing and process-related issues efficiently.
• Recommend and implement process improvements and solutions to support new product introductions and technology transfers.
• Ensure documentation accuracy in compliance with Good Documentation Practices (GDP) and company record retention policies.
• Support and/or lead project-related change controls (CN/CRs) and technical documentation updates.
• Coach and mentor junior engineers or technicians, fostering knowledge-sharing and continuous improvement.
• Adhere to all company guidelines related to health, safety, and environmental practices, ensuring compliance at both individual and team levels.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, Chemical, or related field).
• Master's degree preferred.
• 2–4 years of relevant experience in engineering, manufacturing, or project management, preferably within the medical device or pharmaceutical industry.
• Proven experience in project planning, equipment installation, and process validation.
• Strong analytical, problem-solving, and troubleshooting skills.
• Knowledge of manufacturing processes, equipment qualification, and regulatory compliance (GMP/GDP).
• Familiarity with medical device manufacturing, including catheter-related products, is a plus.
• Proficiency in Microsoft Office and project management tools.
• Advanced English and Spanish communication skills, both written and verbal.
• Ability to work effectively in cleanroom environments and across multifunctional teams.
• Strong leadership and interpersonal skills with the ability to guide and motivate others.

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