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mîrus 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 project management involved.
Position Summary
The Jr Validation Specialist supports validation lifecycle activities related to manufacturing processes, equipment, utilities, software systems, and process improvements. This role is responsible for protocol generation, execution, discrepancy resolution, and validation documentation while ensuring compliance with internal procedures, FDA regulations, and medical device quality standards. The position provides excellent exposure for professionals seeking to expand their validation expertise within a world-class medical device manufacturing environment.
Key Responsibilities
Position Summary
The Jr Validation Specialist supports validation lifecycle activities related to manufacturing processes, equipment, utilities, software systems, and process improvements. This role is responsible for protocol generation, execution, discrepancy resolution, and validation documentation while ensuring compliance with internal procedures, FDA regulations, and medical device quality standards. The position provides excellent exposure for professionals seeking to expand their validation expertise within a world-class medical device manufacturing environment.
Key Responsibilities
- Support full validation lifecycle activities, including planning, execution, and closure of validation efforts.
- Generate, execute, review, and maintain validation protocols and reports (IQ/OQ/PQ).
- Support commissioning and qualification activities for manufacturing equipment, systems, and processes.
- Perform validation assessments, discrepancy investigations, and manage protocol deviations.
- Collaborate with cross-functional teams, including Engineering, Manufacturing, Quality, Automation, and Operations.
- Ensure all documentation complies with Good Documentation Practices (GDP), cGMP, FDA regulations, ISO 13485, and internal quality system requirements.
- Support risk assessments and implementation of corrective and preventive actions (CAPA), as required.
- Participate in troubleshooting activities associated with validation execution and equipment or process performance issues.
- Support change control activities, including validation impact assessments and documentation updates.
- Utilize systems such as SAP and TrackWise to support documentation, investigations, and workflow processes.
- Contribute to continuous improvement initiatives and support execution readiness for ongoing and new projects.
- Bachelor’s Degree in: Engineering, Life Sciences, Chemistry, Biotechnology or a related technical field.
- 1–3 years of experience in one or more of the following areas:
- Validation
- Quality
- Engineering
- Manufacturing support
- Experience within Medical Device, Pharmaceutical, or other regulated industries.
- Experience generating and executing IQ/OQ/PQ validation protocols.
- Working knowledge of: cGMP, GDP, FDA regulations, ISO 13485.
- Familiarity with systems such as: TrackWise, SAP.
- Experience with validation documentation and technical writing.
- Strong troubleshooting, analytical, and problem-solving skills.
- Bilingual (English/Spanish) preferred.