Senior Pharma Process Validation Engineer

Pinnaql, Inc.; Puerto Rico; On-site; USD 95,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (VEG), a Pinnaql company, seeks an experienced engineer to lead process optimization and troubleshooting across operations, manufacturing, pilot plant or capital projects in the pharma/biotech space.

The role applies advanced engineering principles to design and implement major system modifications, develops analyses, and presents results to support regulatory compliant improvements; requires strong documentation and quality systems proficiency, with

Qualifications

• Master's in Engineering with 2+ years experience or Bachelor’s in Engineering with 4+ years experience.
• Experience in aseptic processing environments a plus.
• Familiarity with validation processes and GMP/GxP regulatory guidance.

Responsibilities

• Characterize process optimization strategies and troubleshoot operations in pharma/biotech settings.
• Apply engineering principles to design/implement major system modifications and projects.
• Develop analyses and present results to support regulatory-compliant improvements.

Skills

Bilingual English/Spanish

Regulatory compliance knowledge

Process optimization

Education

Master's in Engineering or Bachelor's with experience

Tools

MS Windows & MS Office

Documentation (URS/DS/IQ/OQ/PQ)

Job description

Validation & Engineering Group, Inc. (VEG), a Pinnaql company, seeks an experienced engineer to lead process optimization and troubleshooting across operations, manufacturing, pilot plant or capital projects in the pharma/biotech space.

The role applies advanced engineering principles to design and implement major system modifications, develops analyses, and presents results to support regulatory compliant improvements; requires strong documentation and quality systems proficiency, with