Senior Process Validation Engineer - Pharma & Biotech

Pinnaql; Carolina (PR); On-site; USD 100,000 - 140,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks an experienced engineer to independently drive process optimization and troubleshooting in pharma manufacturing environments.

You will apply advanced engineering principles to design and implement major system modifications and capital projects, while compiling results for operation teams and regulatory bodies. Ideal candidates have 4+ years in pharma/biotech, aseptic experience preferred, and strong knowledge of cGxP, documentation, and validation

Qualifications

• Engineering degree with pharma/biotech exposure required.
• Bilingual English/Spanish with strong communication skills.
• Experience in validation, PQ/IQ/OQ/PQ protocol development.
• Familiarity with cGxP regulations and GMP environments.

Responsibilities

• Characterize and lead process optimization strategies in manufacturing or capital projects.
• Develop and execute validation plans (IQ/OQ/PQ) and related reports.
• Analyze results, present interpretations, and support regulatory compliance.

Skills

Bilingual EN/ES

Regulatory knowledge

Analytical skills

Project management

SOPs and documentation

Education

Master's in Engineering

Bachelor's in Engineering

Tools

MS Office

Windows

Job description

Validation & Engineering Group, Inc. seeks an experienced engineer to independently drive process optimization and troubleshooting in pharma manufacturing environments.

You will apply advanced engineering principles to design and implement major system modifications and capital projects, while compiling results for operation teams and regulatory bodies. Ideal candidates have 4+ years in pharma/biotech, aseptic experience preferred, and strong knowledge of cGxP, documentation, and validation