Biotech GMP Specialist: Process & Validation

World Courier; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

World Courier seeks a Specialist Manufacturing on-site in Juncos, PR, to support manufacturing and quality systems across non-conformances, process validation, training, and new product introductions.

With advanced degrees and substantial manufacturing experience, the role involves ownership of process documentation, data review, and execution of CAPA/NC closures while collaborating with process development, quality, and compliance teams.

Qualifications

• Must have strong knowledge of bioprocessing unit operations and GMP production.
• Experience supporting drug substance processes and GMP pharmaceutical systems.
• Ability to communicate and collaborate across manufacturing, process development, and quality teams.
• Experience participating in cross-functional teams and presenting to management.

Responsibilities

• Support execution of manufacturing/quality systems including non-conformances, process validation, procedures, training, and new product introductions.
• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assist in process monitoring, CAPA/NC closure, and deviation handling.
• Contribute to process validation protocols and report generation; assist in data analysis.
• Assist with regulatory inspections and NPI/maintenance of documentation systems.
• Support change control and CCRB packages impacting processes.
• Participate in special projects and initiative implementations.

Skills

Bioprocessing understanding

GMP production operations

Regulatory knowledge

Cross-functional leadership

Communication & collaboration

Technical writing

Project management basics

Control charting knowledge

Education

Doctorate degree

Master's degree + 3 years manufacturing ops

Bachelor's degree + 5 years manufacturing ops

Associate's degree + 10 years manufacturing ops

High school diploma / GED + 12 years manufacturing ops

Tools

SAP

TrackWise

PAS/X electronic batch records

Veeva Doc Management

Job description

World Courier seeks a Specialist Manufacturing on-site in Juncos, PR, to support manufacturing and quality systems across non-conformances, process validation, training, and new product introductions.

With advanced degrees and substantial manufacturing experience, the role involves ownership of process documentation, data review, and execution of CAPA/NC closures while collaborating with process development, quality, and compliance teams.