Senior C&Q Engineer - Device Assembly and Packaging

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