Specialist Manufacturing - 35922

Mirus Consulting Group; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

mîrus Consulting Group is seeking a Manufacturing Specialist to provide technical leadership and ensure GMP-compliant manufacturing operations. The role supports deviation management, CAPAs, change control activities, risk assessments, and documentation management while driving continuous improvement and operational efficiency.

Responsibilities include leading investigations, editing CDOC, and collaborating with QA, QC, Engineering, Validation, Supply Chain, and Operations to improve

Qualifications

• Doctorate degree in a related field.
• Master’s degree with 3+ years of Manufacturing Operations experience.
• Bachelor’s degree with 5+ years of Manufacturing Operations experience.

Responsibilities

• Support daily manufacturing operations to ensure safe, compliant, and efficient production processes.
• Lead investigations related to deviations, non-conformances, and process excursions.
• Author, review, and manage CAPAs and Change Controls.
• Perform and document risk assessments of manufacturing processes, product quality, and compliance.
• Serve as a CDOC Editor for controlled manufacturing documentation.
• Collaborate with QA, QC, Engineering, Validation, Supply Chain, and Operations.
• Monitor manufacturing metrics and recommend process improvements.
• Ensure activities comply with GMP regulations, site procedures, and regulatory requirements.
• Support audits, inspections, and regulatory commitments as required.
• Participate in continuous improvement initiatives and operational excellence projects.

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

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 Manufacturing Specialist is responsible for providing technical support and leadership to manufacturing operations, ensuring compliance with quality standards, regulatory requirements, and operational excellence initiatives. This role supports manufacturing processes through deviation management, CAPAs, change control activities, risk assessments, and documentation management while driving continuous improvement and operational efficiency.

Key Responsibilities

• Support daily manufacturing operations to ensure safe, compliant, and efficient production processes.
• Lead and support investigations related to manufacturing deviations, non-conformances, and process excursions.
• Author, review, and manage Corrective and Preventive Actions (CAPAs) and Change Controls (CC).
• Perform and document Risk Assessments to evaluate manufacturing processes, product quality, and compliance risks.
• Serve as a CDOC Editor, ensuring accurate preparation, review, and maintenance of controlled manufacturing documentation.
• Collaborate with cross-functional teams including Quality Assurance, Quality Control, Engineering, Validation, Supply Chain, and Operations.
• Monitor manufacturing metrics and recommend process improvements to enhance productivity, compliance, and product quality.
• Ensure all activities comply with GMP regulations, site procedures, and applicable regulatory requirements.
• Support audits, inspections, and regulatory commitments as required.
• Participate in continuous improvement initiatives and operational excellence projects.

Qualification

One of the following combinations is required:

• Doctorate degree; OR
• Master’s degree and 3 years of Manufacturing Operations experience; OR
• Bachelor’s degree and 5 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.