Senior C&Q Engineer - Device Assembly and Packaging

BioPharma Consulting JAD Group

17h • Onsite

About The Position

Lead commissioning and qualification (C&Q) for device assembly and packaging equipment at a biotechnology company in Juncos, Puerto Rico. The role covers the C&Q strategy through characterization reports and includes overseeing equipment testing and commissioning, preparing and executing qualification documentation, managing validated-system changes and CAPAs, and mentoring junior engineers.

Requirements

• Bachelor's degree in Engineering and 4 years of experience, or a Master's degree and 2 years of experience, or a PhD.
• C&Q experience with full validation-lifecycle documentation.
• Knowledge of GMP, ALCOA+, and electronic document systems.

Nice To Haves

• Experience with device assembly, packaging, or vision systems.

Responsibilities

• Develop the C&Q strategy, system boundaries, and risk assessments using ISPE Baseline and ASTM E2500.
• Oversee factory acceptance testing (FAT), site acceptance testing (SAT), and field commissioning.
• Author IQ/OQ/PQ documentation with URS traceability.
• Write and execute characterization protocols and reports.
• Manage change controls and CAPAs for validated systems.
• Mentor junior engineers.

What This Job Offers

• Career Level: Senior