Senior CQV Engineer: OSD/SDD Validation Lead

Pinnaql, Inc.

Puerto Rico

On-site

USD 120,000 - 160,000

Full time

6 days ago

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Job summary

Validation & Engineering Group in the pharmaceutical sector seeks a Senior CQV Engineer with 10+ years of CQV experience focusing on Oral Solid Dosage (OSD) and Spray-Dried Dispersion (SDD) systems. The role covers commissioning, qualification, startup, and documentation to ensure regulatory compliance.

The successful candidate will lead protocol development, supervise startup activities, and troubleshoot processes while coordinating with manufacturing, quality, and validation teams to ensure

Qualifications

CQV knowledge in pharmaceutical manufacturing and equipment validation.
Experience leading commissioning, qualification, and verification activities.
Ability to develop and execute equipment qualification protocols.

Responsibilities

Lead commissioning, qualification, and verification activities for OSD and SDD systems.
Develop and execute protocols for equipment qualification and validation.
Conduct equipment startup and troubleshooting as needed.
Generate and maintain regulatory-compliant technical documentation.
Collaborate with cross-functional teams to ensure project success.
Provide technical expertise and support to ensure cGMP compliance.

Skills

CQV expertise

Project management

Communication

Problem solving

Education

Bachelor's degree in Engineering

Tools

Tablet presses

Coaters

Dispensing systems

Spray dryers

Qualification protocols

Job description

The successful candidate will lead protocol development, supervise startup activities, and troubleshoot processes while coordinating with manufacturing, quality, and validation teams to ensure

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