Bioprocess Manufacturing Programs Specialist

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 60,000 - 85,000; Part time

Job summary

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico, seeks a Manufacturing Operations Support professional to execute and improve GMP manufacturing and quality systems under minimal supervision. You will handle non-conformances, validations, and change control, and may lead process support systems as primary owner.

The role requires strong bioprocessing knowledge, regulatory familiarity, and ability to work cross-functionally with quality, process development, and manufacturing teams.

Qualifications

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Regulatory knowledge and interactions.
• Ability to participate in and help lead cross‑functional teams.
• Strong communication and collaboration skills with manufacturing, process development, and quality teams.
• Organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure all procedures reflect current operations.
• Assess process performance through inspections and data review; implement improvements.
• Provide troubleshooting support.
• Assist in generating training materials and training.
• Support establishment of process monitoring parameters and control limits.
• Collect process‑monitoring data and support deviation assessments.
• Support timely execution of quarterly process monitoring reports.
• Manage NC/CAPA closure within established timelines.
• Author investigation reports and execute corrective actions.
• May participate in regulatory inspections, NPI, and process or equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for modifications.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Participate in special projects or initiatives as assigned.

Skills

Bioprocessing

GMP operations

Regulatory knowledge

Cross-functional leadership

Communication

Project management

Technical writing

English

Spanish

Documentation

Root Cause Analysis

Education

Doctorate

Master’s

Bachelor’s

Associate’s

High School/GED

Tools

TrackWise

VEEVA

MES

Smartsheet

ChatGPT

Copilot

Power BI

Spotfire

CDOCS

Job description

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico, seeks a Manufacturing Operations Support professional to execute and improve GMP manufacturing and quality systems under minimal supervision. You will handle non-conformances, validations, and change control, and may lead process support systems as primary owner.

The role requires strong bioprocessing knowledge, regulatory familiarity, and ability to work cross-functionally with quality, process development, and manufacturing teams.