Manufacturing Specialist - Process Support and NPI

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.

Requirements

• 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.

Benefits

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