Bioprocess Manufacturing Specialist – Quality & CAPA

Echo-Consulting-Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

On-site work

Job summary

ECHO Consulting Group is seeking professionals to support manufacturing and quality systems across non-conformances, process validation, training, and new product introductions. The role entails applying process expertise and analytical skills to assist with process ownership and improvements in a regulated environment.

The candidate will participate in regulatory inspections, NPI initiatives, change control, and cross-functional projects to ensure compliant and efficient manufacturing

Qualifications

• Doctorate or Master’s with 3+ years of Manufacturing Operations experience.
• Bachelor’s degree with 5+ years of Manufacturing Operations experience.
• Associate degree with 10+ years of experience in manufacturing operations.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance via floor observations and data review; drive improvements.
• Provide troubleshooting support for manufacturing operations.
• Assist in creating training materials and deliver training on process topics.
• Support NC/CAPA closure and coordination with process ownership.

Skills

Bioprocessing basics

GMP operations

Regulatory knowledge

Cross-functional teamwork

Technical writing

Presentation skills

Education

Doctorate degree

Master's degree in Manufacturing Operations

Bachelor's degree in Manufacturing Operations

Associate degree in Manufacturing Operations

High school diploma / GED (with experience)

Job description

ECHO Consulting Group is seeking professionals to support manufacturing and quality systems across non-conformances, process validation, training, and new product introductions. The role entails applying process expertise and analytical skills to assist with process ownership and improvements in a regulated environment.

The candidate will participate in regulatory inspections, NPI initiatives, change control, and cross-functional projects to ensure compliant and efficient manufacturing