Senior C&Q Engineer

Hace 2 días

Juncos, Puerto Rico BioPharma Consulting JAD Group Jornada completa
Lead commissioning and qualification for device assembly and packaging equipment at a leading biotechnology company in Juncos, Puerto Rico, from the C&Q strategy through the characterization reports.

What You'll Do
• Build the C&Q strategy, system boundaries and risk assessments (ISPE Baseline, ASTM E2500)
• Oversee FAT/SAT and field commissioning; author IQ/OQ/PQ with URS traceability
• Write and execute characterization protocols and reports
• Manage change controls and CAPAs on validated systems; mentor junior engineers Requirements
• Bachelor's degree in Engineering + 4 years (or Master's + 2, or PhD)
• C&Q with full validation-lifecycle documentation
• GMP, ALCOA+, electronic document systems
• Device assembly, packaging or vision systems are a strong plus Benefits
• Contract: 6 months, with possible extension
• Shift: Administrative, Monday-Friday
• Start: Immediate