Specialist Manufacturing - 35421

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
We are seeking a highly motivated Specialist Manufacturing to support manufacturing operations within a regulated environment. The ideal candidate will play a key role in ensuring efficient execution of manufacturing processes, supporting deviations and investigations, and driving continuous improvement initiatives while maintaining compliance with GMP and internal quality standards.

Key Responsibilities

• Support daily manufacturing operations to ensure processes are executed in compliance with established procedures and quality standards.
• Lead and/or support deviations and non-conformance investigations, ensuring timely closure and appropriate documentation.
• Conduct root cause analysis using structured tools (e.g., 5 Whys, causal factor analysis) to identify underlying issues and prevent recurrence.
• Develop and maintain technical writing reports, ensuring accuracy, completeness, and compliance with documentation standards.
• Collaborate cross-functionally with Quality, Engineering, Maintenance, and Operations teams to resolve manufacturing issues and improve performance.
• Identify, track, and follow up on corrective and preventive actions (CAPAs) to ensure effectiveness and timely execution.
• Support continuous improvement initiatives, driving efficiency, quality, and compliance within manufacturing processes.
• Project management skills on identifying/tracking actions and achieving due dates.
• Monitor manufacturing performance and provide input for process optimization and operational excellence.
• Ensure adherence to GMP, SOPs, and company policies at all times.
• Participate in inspections, audits, and internal reviews as required.

Minimum Qualifications

• Doctorate degree OR
• Master’s degree + 2 years of Manufacturing Operations experience OR
• Bachelor’s degree + 4 years of Manufacturing Operations experience

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.