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
Specialist Manufacturing is responsible for supporting manufacturing operations in a regulated environment by ensuring compliance with established procedures, quality standards, and continuous improvement initiatives. This role focuses on process optimization, documentation control, and effective implementation of changes to enhance operational efficiency and product quality.
Key Responsibilities
- Execute and support manufacturing activities in compliance with GMP and established procedures
- Lead and support CAPA and CAPA EV processes, including investigations, root cause analysis, and implementation of corrective and preventive actions
- Manage and support Change Control activities to ensure proper assessment, documentation, and execution of process changes
- Develop new manufacturing procedures and enhance existing processes to improve efficiency and compliance
- Modify the current Standard Operating Procedures (SOPs)
- Implement new processes and modify existing ones based on operational needs and continuous improvement initiatives
- Provide training to operators on procedures, process updates, and quality requirements
- Collaborate with cross-functional teams including Quality, Engineering, and Operations
- Ensure all activities are properly documented according to regulatory and internal standards
Qualifications
- Doctorate degree, OR
- Master’s degree with 2+ years of Manufacturing Operations experience, OR
- Bachelor’s degree with 4+ years of Manufacturing Operations experience
- Educational background in Science or Engineering
- Experience working in manufacturing environments with strict procedural compliance
Work Schedule
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.
Specialist
