Validation Engineer (CSV)

Responsibilities

• Generate and execute validation documents, including protocol creation and testing within the bio-pharmaceutical industry
• Create and seek approval for validation documents such as C&Q Plans, URS, Design Specs, Requirements Traceability Matrices, and Summary Reports
• Revise Design Specifications as necessary to align with new design requirements
• Develop qualification protocols for new or modified manufacturing equipment, utilities, and facilities
• Prepare comprehensive summary reports based on the results of validation and qualification tests
• Provide implementation support by collaborating with affected departments and personnel
• Participate in progress meetings to communicate project achievements and necessary action items

Requirements

• Bachelor of Science in Engineering or equivalent
• 5 years of Computer Systems Validation (CSV) experience
• Proven experience within the Bio/Pharmaceutical industry
• Proficiency in Commissioning & Qualification (C&Q) documentation
• Knowledge of CSV regulations including cGMP, ISPE GAMP, 21 CFR Part 11, 21 CFR 211.68, and Data Integrity
• Fluency in both English and Spanish (written and verbal)
• Ability to work onsite in Juncos, PR

About the Company

Avante Engineering LLC was founded in 2019 with a vision centered on delivering a personalized approach to engineering and technical services. We provide expert consultation, project management solutions, and technical services to the Pharmaceuticals, Biotechnology, and Medical Devices Manufacturing industries.