Own manufacturing deviations from triage to closure in a drug substance operation at a leading biotechnology company in Juncos, Puerto Rico. This role is for people who have led investigations themselves, not only supported them.

What you'll do

• Own nonconformances: triage, investigation, root cause, CAPA and on-time closure.
• Use RCA tools (Fishbone, 5 Whys, Kepner-Tregoe) and write clear investigation reports.
• Revise manufacturing procedures and support process monitoring.
• Support change controls and new product introductions.

Requirements

• Bachelor's degree + 4 years (or Associate's + 8, or High School + 10) in manufacturing operations.
• Deviation/investigation owner experience in GMP manufacturing (required).
• Bioprocessing unit operations, Lean, GDP.
• TrackWise, Veeva, MES, CDOCS; Smartsheet and Power BI are a plus.
• Bilingual English/Spanish.

Benefits

• Contract: 4 months, with possible extension
• Shift: Administrative, Monday–Friday 8:00 am–5:00 pm (overtime as needed)
• Start: Immediate