Senior C&Q Engineer - Device Assembly and Packaging

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a senior C&Q professional to lead commissioning and qualification for device assembly and packaging equipment in Juncos, Puerto Rico. You will drive C&Q strategy, oversee FAT/SAT, and author IQ/OQ/PQ with URS traceability.

Responsibilities include writing characterization protocols, managing change controls, CAPAs, and mentoring junior engineers. Immediate start on a 6-month contract with potential extension.

Qualifications

• Bachelor's degree in Engineering required; 4 years of experience for consideration, or Master's degree with 2 years, or PhD.
• C&Q with full validation-lifecycle documentation is required.
• GMP experience and ALCOA+ principles; familiarity with electronic document systems.

Responsibilities

• Lead the commissioning and qualification for device assembly and packaging equipment from C&Q strategy to characterization reports.
• Oversee FAT/SAT and field commissioning; author IQ/OQ/PQ withURS traceability.
• Write and execute characterization protocols and reports.
• Manage change controls and CAPAs on validated systems; mentor junior engineers.

Skills

Device assembly

Packaging systems

Vision systems

GMP

ALCOA+

Electronic document systems

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