Senior Process Validation Engineer - Aseptic Pharma

Pinnaql, Inc.; Barceloneta (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a qualified engineer to lead characterization and optimization of manufacturing processes in aseptic environments. The role focuses on troubleshooting, system modifications, and validation activities across labs and production lines.

Applicants should have 4+ years in pharma/biotech, familiarity with GLPs/GMPs, and strong documentation skills. This is an on-site role in a regulated facility requiring bilingual communication in English and Spanish.

Qualifications

• Masters or higher in engineering with relevant pharmaceutical/biotech experience.
• Experience in aseptic processing environments, including Fill/Finish operations.
• Solid understanding of cGxP and regulatory expectations and documentation.

Responsibilities

• Characterize and optimize processes; troubleshoot operational issues in manufacturing or capital projects.
• Design, implement, and oversee major system modifications and validation activities.
• Develop, organize, analyze and present results from complex engineering projects.

Skills

Aseptic processing

Regulatory compliance

Process characterization

SDLC & Validation

Bilingual English/Spanish

Data integrity

Analytical problem solving

MS Office

Education

Masters in Engineering

Bachelors in Engineering

Tools

Lab equipment operation

IQ/OQ/PQ protocols

Job description

Validation & Engineering Group, Inc. seeks a qualified engineer to lead characterization and optimization of manufacturing processes in aseptic environments. The role focuses on troubleshooting, system modifications, and validation activities across labs and production lines.

Applicants should have 4+ years in pharma/biotech, familiarity with GLPs/GMPs, and strong documentation skills. This is an on-site role in a regulated facility requiring bilingual communication in English and Spanish.