Manufacturing Process Specialist: Change Control & CAPA

Mirus Consulting Group; Juncos (PR); On-site; USD 85,000 - 105,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, is seeking a Specialist Manufacturing to provide technical support in a regulated environment. The role leads change controls, supports deviation investigations, drives process improvements, and collaborates across functions to ensure manufacturing readiness and compliance.

You will analyze data, manage documentation, and assist with training, CAPA assessments, and master batch record activities.

Qualifications

• Must have higher degree in Life Sciences or Engineering and manufacturing operations experience.
• Experience with bioprocessing unit operations and regulatory documentation practices.
• GDP in regulated environments and cross-functional collaboration are essential.

Responsibilities

• Own change controls for manufacturing process changes.
• Lead deviation investigations and CAPA including root cause analysis.
• Support risk assessments and microbial assessment evaluations.
• Coordinate campaign readiness and cross-functional communication.
• Develop and maintain training materials and assist on-the-floor troubleshooting.
• Create and revise Master Batch Records and related documentation.
• Assess process performance and implement improvement opportunities.

Skills

Communication skills

Technical writing

Presentation skills

Bilingual English/Spanish

Education

Doctorate degree in Life Sciences or Engineering

Master’s degree in Life Sciences or Engineering

Bachelor’s degree in Life Sciences or Engineering

Tools

TrackWise

Spotfire

CDOCS

Process Monitoring Platforms

Job description

mîrus Consulting Group in Humacao, Puerto Rico, is seeking a Specialist Manufacturing to provide technical support in a regulated environment. The role leads change controls, supports deviation investigations, drives process improvements, and collaborates across functions to ensure manufacturing readiness and compliance.

You will analyze data, manage documentation, and assist with training, CAPA assessments, and master batch record activities.