Senior Validation Engineer - Pharma/Biotech, PQ & NPI

Veg Group; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Senior Engineer to independently characterize and optimize processes in operations, manufacturing, pilot plants, or capital projects.

You will apply advanced engineering principles to design major system modifications and analyze results for complex projects. The role requires experience in aseptic processing, PQ/IQ/OQ/PQ protocols, and strong regulatory knowledge.

Qualifications

• Masters + 2 years of engineering experience OR Bachelors in Engineering + 4 years of engineering experience. Preferred: Mechanical or Chemical Engineering
• Experience in aseptic processing environments including Fill/Finish operations such as vial and syringe filling lines
• Experience in design documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation

Responsibilities

• Independently provides and/or directs characterization of process optimization strategies and troubleshooting of operational issues.
• Applies advanced engineering principles to design and implement major system modifications, experiments, process and/or capital projects.
• Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Skills

Pharma/biotech processes

Documentation in regulated env

GLPs and GMPs

Engineering problem solving

MS Windows / MS Office

Education

Masters + 2 years eng exp

Bachelors in Engineering + 4 years exp

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. seeks a Senior Engineer to independently characterize and optimize processes in operations, manufacturing, pilot plants, or capital projects.

You will apply advanced engineering principles to design major system modifications and analyze results for complex projects. The role requires experience in aseptic processing, PQ/IQ/OQ/PQ protocols, and strong regulatory knowledge.