Bioprocess Manufacturing Programs Specialist

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 89,000 - 134,000; Full time

Job summary

BioPharma Consulting JAD Group seeks an experienced professional to support manufacturing and quality systems and act as a document owner for procedures and validation studies. This role involves troubleshooting, data analysis, and cross‑functional collaboration across manufacturing, process development, and quality teams.

Responsibilities include generating training materials, monitoring process performance, and assisting with regulatory inspections and NPIs.

Qualifications

• PhD or relevant advanced degree with manufacturing operations experience.
• Experience with bioprocessing unit operations and Lean practices.
• Excellent communication in English and Spanish; ability to lead cross-functional teams.

Responsibilities

• Support execution of manufacturing and quality systems (NCRs, CAPAs, process validation).
• Assist in creating and revising procedures; own documents.
• Provide troubleshooting and data-driven process improvements.
• Assist in training materials and training delivery.
• Support process monitoring parameters and control limits.
• Collect data for process validation and deviation assessments.
• Participate in regulatory inspections and NPIs as needed.

Skills

Bioprocessing

GMP production

Regulatory knowledge

Cross-functional teams

Communication

Project management

Control charting

Education

Doctorate

Master’s + 2 years Manufacturing Operations

Bachelor’s + 4 years Manufacturing Operations

Associate’s + 8 years Manufacturing Operations

High School/GED + 10 years Manufacturing Operations

Tools

TrackWise

VEEVA

MES

Smartsheet

ChatGPT

Copilot

Power BI

Spotfire

CDOCS

Job description

BioPharma Consulting JAD Group seeks an experienced professional to support manufacturing and quality systems and act as a document owner for procedures and validation studies. This role involves troubleshooting, data analysis, and cross‑functional collaboration across manufacturing, process development, and quality teams.

Responsibilities include generating training materials, monitoring process performance, and assisting with regulatory inspections and NPIs.