Bioprocess Floor Operations Specialist (NPI & CAPA)

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico, seeks a hands-on manufacturing operations supporter to ensure GMP on the floor, own procedures, troubleshoot, and drive NCs/CAPAs to closure while supporting NPI and change control.

Requirements: Bachelor's + 4 years GMP floor experience, strong technical writing, basic project management, and bilingual English/Spanish. Shift: administrative; 12-month contract.

Qualifications

• Bachelor’s degree and 4+ years of GMP manufacturing floor experience or equivalent.
• Hands-on manufacturing floor support in a GMP environment.
• Strong technical writing and basic project management skills.
• Experience writing/managing manufacturing procedures, investigations and CAPAs.
• NPI and CCRB/change control support is a plus.
• Bilingual English/Spanish.

Responsibilities

• Assess process performance by observing floor operations and reviewing data.
• Initiate, revise and approve manufacturing procedures as document owner.
• Provide process troubleshooting support.
• Triage nonconformances and close NC/CAPAs on time.
• Support process monitoring, validation protocols, and data analysis.
• Participate in NPI processes, documentation, training and equipment needs.
• Assist the change owner on CCRB packages and participate in inspections.

Skills

GMP manufacturing

Bioprocessing

Technical writing

Project management

Bilingual English/Spanish

Education

Bachelor's degree + 4 years manufacturing operations experience

Job description

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico, seeks a hands-on manufacturing operations supporter to ensure GMP on the floor, own procedures, troubleshoot, and drive NCs/CAPAs to closure while supporting NPI and change control.

Requirements: Bachelor's + 4 years GMP floor experience, strong technical writing, basic project management, and bilingual English/Spanish. Shift: administrative; 12-month contract.