Senior Validation Engineer – Pharmaceutical/Biotech

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

Job summary

Validation & Engineering Group, Inc. seeks a seasoned engineer to independently characterize process optimization strategies and troubleshoot complex operational issues across manufacturing, pilot plants, and capital projects.

The role applies advanced engineering principles to design and implement major system modifications and to present interpretations of results for significant projects. Requirements include 4+ years in pharma/biotech/medical devices, aseptic experience, PQ/NPI exposure, and

Qualifications

• Experience in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines.
• Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI).
• Minimum of 4 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Proficient using MS Windows and Microsoft Office applications.
• Strong knowledge of cGxP and regulatory guidance and understanding of how they are applied to regulatory compliance.
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, FAT & Site Acceptance Test (SAT).
• Available to work extended hours, weekends and holidays.

Responsibilities

• Independently provides and/or directs the characterization of process optimization strategies and troubleshooting of operational issues in operations, manufacturing, pilot plant or capital projects environments.

Job description

Validation & Engineering Group, Inc. seeks a seasoned engineer to independently characterize process optimization strategies and troubleshoot complex operational issues across manufacturing, pilot plants, and capital projects.

The role applies advanced engineering principles to design and implement major system modifications and to present interpretations of results for significant projects. Requirements include 4+ years in pharma/biotech/medical devices, aseptic experience, PQ/NPI exposure, and