Manufacturing Specialist - Process Support and NPI

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

Support manufacturing operations from the floor at a leading biotechnology company in Juncos, Puerto Rico. With minimal supervision, you will own procedures, troubleshoot the process, drive nonconformances and CAPAs to closure, and support new product introductions and change control.

What you'll do

• Assess process performance by observing floor operations and reviewing performance data; plan and implement improvements.
• Initiate, revise and approve manufacturing procedures as document owner; help build training materials.
• Provide process troubleshooting support.
• Triage nonconformances, author investigation reports, execute corrective actions and close NC/CAPAs on time; monitor and communicate trends.
• Support process monitoring (control limits, quarterly reports) and process validation protocols, execution and data analysis.
• Participate in the NPI process to assess documentation, materials, training and equipment modification needs.
• Assist the manufacturing change owner on CCRB packages; participate in regulatory inspections and special projects.

• Bachelor's degree + 4 years of manufacturing operations experience (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate).
• Hands-on manufacturing floor support experience in a GMP environment.
• Detailed technical understanding of bioprocessing unit operations.
• Experience writing and approving manufacturing procedures, nonconformance investigations and CAPAs.
• NPI and change control (CCRB) support experience is a plus.
• Strong technical writing, presentation and basic project management skills; basic control charting.
• Bilingual English/Spanish.

• Contract: 12 months, with possible extension
• Shift: Administrative; non-standard shift may be required