Investigation Owner, Manufacturing Deviations

Mirus Consulting Group; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Specialist Manufacturing to lead deviation investigations and drive timely resolutions. You will serve as the investigation owner, perform root cause analyses, and collaborate with Manufacturing, Engineering, Quality, Validation, and other groups to ensure compliance and continuous improvement.

Ideal candidates will have experience in biotech, pharmaceutical, or regulated manufacturing environments and a background in managing

Qualifications

• Doctorate or Master’s degree with Manufacturing Operations experience.
• Bachelor’s degree with 4 years of Manufacturing Operations experience, engineering is a plus.

Responsibilities

• Lead and manage manufacturing deviation investigations from initiation through closure.
• Serve as the investigation owner, ensuring timely completion of investigations and documentation.
• Conduct detailed root cause analyses to identify underlying causes of manufacturing events and deviations.
• Evaluate impact of deviations on processes, product quality, compliance, and operations.
• Utilize TrackWise or similar quality systems to document and track investigations.
• Partner with cross-functional teams to implement corrective actions and CAPAs where applicable.
• Support regulatory readiness and site procedures compliance.

Skills

Deviation management

Investigation ownership

Root cause analysis

Quality systems

CAPA

GxP knowledge

Cross-functional collaboration

Documentation

Analytical thinking

Education

Doctorate degree

Master's degree

Bachelor's degree

Engineering degree

Tools

TrackWise

Quality management systems

Job description

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Specialist Manufacturing to lead deviation investigations and drive timely resolutions. You will serve as the investigation owner, perform root cause analyses, and collaborate with Manufacturing, Engineering, Quality, Validation, and other groups to ensure compliance and continuous improvement.

Ideal candidates will have experience in biotech, pharmaceutical, or regulated manufacturing environments and a background in managing