Validation Specialist - Packaging Equipment

About This Role

The Validation Specialist will ensure compliance for packaging equipment within the pharmaceutical, medical device, or biotechnology industries. This role involves developing and executing validation protocols and managing commissioning documentation.

Responsibilities

• Develop and execute IQ, OQ, PQ protocols for packaging equipment
• Generate deviations and reports
• Ensure compliance with cGxP and regulatory guidance
• Support Commissioning and Design Documentation (URS, DS)
• Perform Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
• Contribute to SDLC, Risk Assessment, and Data Integrity initiatives

Requirements

• 3+ years experience in pharmaceutical, medical device or biotechnology industries
• Experience with biotech packaging equipment (Vial filling, Syringe Filling, Lyophilization, Isolators, labelers, cartoner, serialization, inspection)
• Fully bilingual (English / Spanish) with excellent oral skills
• Proficient in MS Windows and Microsoft Office applications
• Strong knowledge of cGxP and regulatory guidance and their application to regulatory compliance
• Experience in Commissioning and Design Documentation (URS, DS)
• Experience with IQ, OQ, PQ protocols development and execution
• Experience with SDLC, Risk Assessment, Data Integrity, FAT & SAT
• Technical Writing skills and investigations processes

Qualifications

• Bachelor's Degree in Science or Engineering
• Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries

Skills

* Required skills