Manufacturing Specialist — GMP & Process Improvement

Echo-Consulting-Group; Puerto Rico; On-site; USD 85,000 - 120,000; Full time

Job summary

ECHO Consulting Group is seeking a Manufacturing Operations professional to support GMP production, document control, and process validation in a regulated setting. You will work with cross-functional teams to drive process improvements and ensure adherence to quality systems.

Responsibilities include procedure management, non-conformance handling, CAPA execution, and training support. Strong writing, analytical, and project skills are essential for success in this on-site role in Juncos, PR.

Qualifications

• PhD or MS with relevant manufacturing operations experience required.
• Alternative: Bachelor's with significant manufacturing operations experience.
• Additional path: Associate's with extensive operations background or high school diploma with long experience.

Responsibilities

• Initiate, revise, and approve manufacturing procedures and own documents.
• Assess process performance and implement optimization solutions.
• Provide troubleshooting support for process issues.
• Assist in training material development and execution on scientific/technical topics.
• Support establishment of process monitoring parameters and quarterly reports.
• Triages non-conformances and supports CAPA and root-cause analysis.
• Assist in generation of process validation protocols and reports.
• May participate in regulatory inspections and NPI activities.

Skills

Bioprocessing knowledge

GMP production operations

Regulatory knowledge

Cross-functional teamwork

Communication

Technical writing

Project management basics

Control charting basics

Education

Doctorate or Master's in related field with manufacturing ops experience

Bachelor's degree with manufacturing ops experience

Associate’s degree with manufacturing ops experience

High school diploma/GED with extensive manufacturing ops exp

Tools

Veeva Vault (CDOCs)

Smartsheet

Job description

ECHO Consulting Group is seeking a Manufacturing Operations professional to support GMP production, document control, and process validation in a regulated setting. You will work with cross-functional teams to drive process improvements and ensure adherence to quality systems.

Responsibilities include procedure management, non-conformance handling, CAPA execution, and training support. Strong writing, analytical, and project skills are essential for success in this on-site role in Juncos, PR.