Bioprocess Manufacturing Specialist & Process Owner

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks a Manufacturing Specialist to support execution and continuous improvement of core manufacturing and quality systems with minimal supervision. You will apply process expertise, operational knowledge, scientific understanding, compliance fundamentals, and strong analytical/troubleshooting skills to ensure robust, efficient, and compliant manufacturing operations.

The Specialist may act as primary production process owner for designated systems, contribute to

Qualifications

• Doctorate or equivalent level of education may be required as stated in the qualifications.
• Experience in manufacturing operations and regulatory compliance is expected.
• Strong analytical and problem-solving skills are required.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; act as document owner ensuring alignment with current operations.
• Assess process performance through floor observation and data review; identify, plan, and implement process improvement opportunities.
• Provide troubleshooting support to resolve process-related issues.
• Assist in developing training materials and deliver technical/scientific training as needed.
• Support establishment of process monitoring parameters and control limits.
• Collect and analyze process-monitoring data; assist in deviation assessments.
• Lead cross-functional meetings to ensure timely progression and closure of Change Control records.

Skills

Bioprocessing unit operations

GMP production operations

Data trending

Technical writing

Presentation abilities

Project management

Education

Doctorate

Master’s + 2 years Manufacturing Operations experience

Bachelor’s + 4 years Manufacturing Operations experience

Associate’s + 8 years Manufacturing Operations experience

High School/GED + 10 years Manufacturing Operations experience

Tools

TrackWise

SAP

Job description

Biopharma-Consulting-Jad-Group seeks a Manufacturing Specialist to support execution and continuous improvement of core manufacturing and quality systems with minimal supervision. You will apply process expertise, operational knowledge, scientific understanding, compliance fundamentals, and strong analytical/troubleshooting skills to ensure robust, efficient, and compliant manufacturing operations.

The Specialist may act as primary production process owner for designated systems, contribute to