mirus 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 involved project management.

Job Description:
We are seeking a detail-oriented and proactive Validation Engineer to support the development and launch of a new medical device. This role is responsible for planning, executing, and documenting validation activities throughout the product development lifecycle, ensuring compliance with regulatory and quality standards. The ideal candidate will work closely with R&D, Quality, Regulatory, and Manufacturing teams to ensure that all equipment, processes, and systems meet intended use and performance requirements.

Key Responsibilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems related to new product development.
• Support the creation of validation plans, traceability matrices, and risk assessments (e.g., FMEA).
• Ensure all validation activities are performed in compliance with applicable regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Collaborate with cross-functional teams to support process development, technology transfer, and design verification/validation.
• Review and approve validation-related documentation and provide technical input during design reviews.
• Maintain detailed and organized records of validation activities to support audits and regulatory submissions.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 2+ years of experience in validation within the medical device or regulated industry.
• Solid knowledge of validation principles and regulatory requirements.
• Experience with equipment, process, or software validation (depending on scope).
• Familiarity with design control and product lifecycle documentation.
• Strong technical writing, organizational, and communication skills.
• Fluent in English (written and spoken).

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.