Senior C&Q Engineer: Risk, Validation & Commissioning

Cis-International-LLC; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Cis-International-LLC is seeking a senior Commissioning & Qualification (C&Q) professional to lead risk assessments, develop C&Q strategies and oversee IQ/OQ/PQ activities for complex pharmaceutical systems in Puerto Rico. The role requires collaboration with Engineering, Validation, QA, Manufacturing and Supply Chain to ensure GMP-compliant delivery.

You will manage documentation, CAPAs and change controls, mentor junior staff, and drive project execution within scope, budget and schedule while

Qualifications

• Doctorate or Masters with 2+ years engineering experience.
• Bachelors in Engineering with 4+ years engineering experience.
• Experience in design engineering and project execution.

Responsibilities

• Independently provides and/or directs characterization and optimization efforts.
• Applies advanced engineering principles to major system modifications and projects.
• Develops, organizes, analyzes and presents interpretation of results for operational issues or projects.
• Lead and coordinate cross-functional teams including QA, Validation and Manufacturing.
• Prepare and support validation summary reports.

Skills

Engineering knowledge

GLP/GMP familiarity

Technical communication

Team leadership

Problem solving

Education

Doctorate

Masters + 2 years exp

Bachelors in Engineering + 4 years exp

Tools

Laboratory equipment

Computers/分析 tools

Job description

Cis-International-LLC is seeking a senior Commissioning & Qualification (C&Q) professional to lead risk assessments, develop C&Q strategies and oversee IQ/OQ/PQ activities for complex pharmaceutical systems in Puerto Rico. The role requires collaboration with Engineering, Validation, QA, Manufacturing and Supply Chain to ensure GMP-compliant delivery.

You will manage documentation, CAPAs and change controls, mentor junior staff, and drive project execution within scope, budget and schedule while