Validation Engineer - Remote

Overview

Sequoia is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.

In Short

• Generate and execute life cycle documentation for cleaning, shipping, facilities, utilities, systems, equipment, and processes.
• Support validation activities for Basecamp and client Tech Transfer projects.
• Write, review, and revise various qualification/verification related documents.
• Write reports to summarize validation activities.
• Write procedures, investigations, protocols, and reports to support Maintenance and Engineering departments.
• Perform P&ID Walkdowns and Thermal mapping of temperature-controlled chambers.
• Support the resolution of regulatory observations or manufacturing site issues.
• Execute periodic reviews and requalification for temperature chambers.

Requirements

• Bachelor’s degree in a related life science field.
• 4-7 years of experience in the biotech, pharmaceutical, or medical device industry.
• Knowledge and experience with FDA cGMP, FMEA, and Risk Analysis.
• Validation expertise in Equipment, CSV, Method, and Process.
• Protocol generation experience of automated production systems.
• Report writing experience for IQ, OQ, PQ, and CSV.
• Strong verbal and written communication skills.

Benefits

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Generous flexible paid time off program.
• Company paid holidays.
• Flexible working hours and fully remote work options.