Manufacturing Specialist - Process Support and NPI

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a capable manufacturing operations support professional for our Juncos, Puerto Rico site. You will own procedures on the floor, troubleshoot processes, drive NC/CAPAs to closure, and support new product introductions and change control.

Responsibilities include assessing process performance, training material creation, and collaborating on CCRB packages. Fluency in English and Spanish is required; 12-month contract with non-standard shifts may be needed.

Qualifications

• Hands-on manufacturing floor support in a GMP environment.
• Detailed technical understanding of bioprocessing unit operations.
• Experience writing and approving manufacturing procedures, investigations and CAPAs.
• Experience with NPI and CCRB change control is a plus.
• Bilingual English/Spanish with strong technical writing skills.

Responsibilities

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

Skills

GMP environment experience

Bioprocessing unit operations

Manufacturing procedures writing/appro

Nonconformance investigations & CAPAs

NPI & CCRB change control

Technical writing & presentation

Project management basics

Control chart knowledge

Bilingual English/Spanish

Education

Bachelor's degree + 4 years manufacturing ops exp (or Master's +2)

Associate's + 8 years

High School + 10 years

Doctorate

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