Specialist Manufacturing - 35251

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its services include theassessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensiveproject management supportto ensure compliance, efficiency, and operational excellence.

Position Summary
TheManufacturing Specialistis responsible for supporting day‑to‑day manufacturing operations in a GMP‑regulated environment. This role ensures manufacturing processes are executed in compliance with established procedures, regulatory requirements, and quality standards. The Manufacturing Specialist plays a key role in deviation documentation, change control execution, and continuous improvement initiatives while supporting operational efficiency and compliance.

Key Responsibilities

• Support daily manufacturing operations within a pharmaceutical GMP environment, ensuring adherence to batch records, standard operating procedures (SOPs), and safety requirements.
• Lead and supportdeviation documentation, investigation, and resolution in alignment with site procedures and quality standards.
• Manage and executeChange Controlactivities, including assessment, documentation, impact analysis, and implementation.
• Collaborate cross‑functionally with Quality, Engineering, Validation, and Supply Chain to resolve operational issues and support process improvements.
• Participate in continuous improvement initiatives to enhance process efficiency, compliance, and operational robustness.
• Support audits and regulatory inspections by providing documentation, data, and subject matter expertise.

Required Education & Experience
Candidates must meetoneof the following education and experience requirements:

• Doctorate degreeOR
• Master’s degree plus2 yearsof Manufacturing Operations experienceOR
• Bachelor’s degree plus4 yearsof 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.