Senior Validation Engineer - Aseptic & GMP

Pinnaql, Inc.; Juana Díaz (PR); On-site; USD 95,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a talented engineer in Puerto Rico to lead process optimization studies and troubleshoot operations in manufacturing, pilot plants, or capital projects.

You will apply advanced engineering principles to design major system modifications and deliver analysis and results for complex projects. The ideal candidate has aseptic filling experience, PQ/NPI exposure, 4+ years in pharma/biotech, and strong regulatory knowledge.

Qualifications

• Masters + 2 years of engineering experience or Bachelors + 4 years in engineering preferred.
• Experience in aseptic processing environments (Fill/Finish) preferred.
• Knowledge of validation processes (IQ/OQ/PQ) and GMP/cGxP.

Responsibilities

• Characterizes and guides process optimization strategies and troubleshooting in operations, manufacturing, pilot plant or capital projects.
• Applies engineering principles to design and implement major system modifications and projects.
• Develops, analyzes and presents results for complex operational issues or engineering projects.

Skills

Bilingual English/Spanish

Process engineering

Regulatory compliance

Education

Master's degree in Engineering

Bachelor's degree in Engineering

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. seeks a talented engineer in Puerto Rico to lead process optimization studies and troubleshoot operations in manufacturing, pilot plants, or capital projects.

You will apply advanced engineering principles to design major system modifications and deliver analysis and results for complex projects. The ideal candidate has aseptic filling experience, PQ/NPI exposure, 4+ years in pharma/biotech, and strong regulatory knowledge.