Senior C&Q Engineer - Device Assembly and Packaging

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 90,000 - 120,000; Part time

Job summary

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico, seeks a C&Q engineer to lead commissioning and qualification for device assembly and packaging equipment, guiding the lifecycle from ISPE Baseline strategies to characterization reports. You will build C&Q strategy, oversee FAT/SAT and field commissioning, author IQ/OQ/PQ with URS traceability, and write characterization protocols.

Requires engineering degree with 4+ years (or MS with 2, or PhD), GMP/ALCOA+, and experience with validated

Qualifications

• C&Q with full validation-lifecycle documentation.
• GMP, ALCOA+, electronic document systems.
• Device assembly, packaging or vision systems are a strong plus.

Responsibilities

• Lead 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.

Skills

GMP compliance

ALCOA+

Change control

Documentation

Education

Bachelor's degree in Engineering

Master's degree

PhD

Job description

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.

• 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.

• Contract: 6 months, with possible extension
• Shift: Administrative, Monday-Friday
• Start: Immediate