Bioprocess Manufacturing Specialist — NPI & CAPA

ProQuality Network; Juncos (PR); Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProQuality Network is seeking a Manufacturing Specialist to support regulated production environments and quality systems. You will work with minimal supervision to execute and improve manufacturing processes, CAPA, and documentation across NPI and change initiatives.

The role requires proactive problem-solving, collaboration with Operations, Quality, Engineering, and Maintenance, and strong understanding of cGMP practices in a fast-paced facility.

Qualifications

• Bachelor's degree or higher in Engineering, Biotechnology, Life Sciences, Chemistry, or related technical discipline.
• Experience in regulated manufacturing environments such as biotech, pharma, or medical devices.
• Hands-on process engineering, manufacturing support, or production systems experience.
• Familiarity with automation systems, equipment, and continuous improvement methods like Lean Six Sigma and Kaizen.

Responsibilities

• Initiate, revise, review, and approve manufacturing procedures while ensuring documentation reflects current operations.
• Serve as a document owner for assigned procedures and records.
• Monitor process performance via floor observations and data analysis.
• Identify, evaluate, and implement process improvement opportunities.
• Provide technical troubleshooting support for manufacturing operations.
• Assist in developing training materials and delivering technical training.

Skills

Bioprocessing

GMP knowledge

CAPA

Process troubleshooting

Cross-functional teamwork

Data analysis

Education

Bachelor's Degree in Engineering

Master's Degree in relevant field

Job description

ProQuality Network is seeking a Manufacturing Specialist to support regulated production environments and quality systems. You will work with minimal supervision to execute and improve manufacturing processes, CAPA, and documentation across NPI and change initiatives.

The role requires proactive problem-solving, collaboration with Operations, Quality, Engineering, and Maintenance, and strong understanding of cGMP practices in a fast-paced facility.