Manufacturing Process Specialist — cGMP & Lean Excellence

Mirus Consulting Group; Juncos (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico is seeking a Specialist Manufacturing to provide technical and operational support in a regulated environment. The role focuses on safe, efficient production and ongoing improvement across cross-functional teams.

Responsibilities include troubleshooting, CAPA execution, process validation, equipment qualification, and documentation. Candidates should have advanced engineering credentials with experience in regulated manufacturing settings.

Qualifications

• Doctorate, or Master's with 2 years of Manufacturing Operations experience.
• Bachelor's with 4 years of Manufacturing Operations experience.
• Preferred background in Chemical, Mechanical, Industrial Engineering or Biotechnology.

Responsibilities

• Provide technical support to manufacturing operations to ensure safe, efficient, and compliant production activities.
• Evaluate processes for optimization, productivity gains, and waste reduction.
• Troubleshoot process issues and drive CAPA activities.
• Support investigations related to deviations, non-conformances, and excursions.
• Collaborate with cross-functional teams to resolve manufacturing challenges.
• Monitor performance indicators and recommend improvements.
• Support process validation, equipment qualification, tech transfer, and startup activities.
• Ensure compliance with cGMP and regulatory requirements.
• Participate in continuous improvement initiatives using Lean Six Sigma, Kaizen, and RCA.
• Prepare, review, and update manufacturing documentation.

Skills

Communication skills

Cross-functional teamwork

Problem solving

Education

Doctorate degree

Master's degree

Bachelor's degree

Tools

Lean Six Sigma

Kaizen

Root Cause Analysis

Job description

mîrus Consulting Group in Humacao, Puerto Rico is seeking a Specialist Manufacturing to provide technical and operational support in a regulated environment. The role focuses on safe, efficient production and ongoing improvement across cross-functional teams.

Responsibilities include troubleshooting, CAPA execution, process validation, equipment qualification, and documentation. Candidates should have advanced engineering credentials with experience in regulated manufacturing settings.