Manufacturing Specialist - Process Support and NPI

BioPharma Consulting JAD Group

5d • Onsite

About The Position

Support manufacturing operations from the floor at a biotechnology company in Juncos, Puerto Rico. With minimal supervision, the role owns procedures, troubleshoots processes, drives nonconformances and CAPAs to closure, and supports new product introductions and change control.

The position assesses process performance through floor observation and performance-data review, plans and implements improvements, and provides process troubleshooting. It also supports process monitoring and validation, participates in NPI and change-control activities, and contributes to regulatory inspections and special projects.

Requirements

• Bachelor's degree and 4 years of manufacturing operations experience, or a Master's degree and 2 years, an Associate degree and 8 years, a high school diploma and 10 years, 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.
• Strong technical writing and presentation skills.
• Basic project management skills and basic control charting skills.
• Bilingual in English and Spanish.

Nice To Haves

• Experience supporting NPI and change control (CCRB).

Responsibilities

• Assess process performance by observing floor operations and reviewing performance data; plan and implement improvements.
• Initiate, revise, and approve manufacturing procedures as document owner, and help develop training materials.
• Provide process troubleshooting support.
• Triage nonconformances, author investigation reports, execute corrective actions, and close nonconformances and CAPAs on time; monitor and communicate trends.
• Support process monitoring, including control limits and quarterly reports, as well as 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 with CCRB packages.
• Participate in regulatory inspections and special projects.

What This Job Offers

• Career Level: Mid Level