Senior Validation Engineer – Pharma & Biotech

Pinnaql, Inc.; Manatí (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks an engineer to lead process optimization and troubleshoot operations in manufacturing and capital projects, applying advanced engineering principles to design and implement major system modifications.

Candidates will develop, organize, analyze and present results, with 4+ years in pharma/biotech, preference for aseptic Fill/Finish, and bilingual English/Spanish. Travel expectations modest; GMP/cGxP knowledge required.

Qualifications

• Masters + 2 years of engineering experience or Bachelor + 4 years in engineering, preferred mechanical/chemical.
• Experience in pharmaceutical/biotech processes and validation documentation.
• Bilingual English/Spanish with strong oral skills.
• Familiarity with GLPs and GMPs; ability to apply engineering concepts to production.

Responsibilities

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

Skills

Aseptic processing

PQ / validation

Regulatory compliance

Data interpretation

SDLC

GMP / cGxP

Microsoft Office

Lab equipment operation

Education

Masters in Engineering

Bachelors in Engineering

Tools

MS Windows

Microsoft Office

Documentation (URS/DS)

Job description

Validation & Engineering Group, Inc. in Puerto Rico seeks an engineer to lead process optimization and troubleshoot operations in manufacturing and capital projects, applying advanced engineering principles to design and implement major system modifications.

Candidates will develop, organize, analyze and present results, with 4+ years in pharma/biotech, preference for aseptic Fill/Finish, and bilingual English/Spanish. Travel expectations modest; GMP/cGxP knowledge required.