Validation Engineer

You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Validation Engineer to execute process validation activities across the full validation lifecycle for biologics manufacturing. The primary responsibilities include supporting both upstream and downstream manufacturing processes, authoring and reviewing validation documentation, performing data analysis, and ensuring alignment with regulatory expectations and industry best practices.

Key Responsibilities

• Execute process validation activities across the full validation lifecycle for biologics manufacturing.
• Support upstream and downstream manufacturing processes, including chromatography operations and parameter evaluation.
• Author and review validation documentation, including Validation Master Plans (VMPs), protocols, reports, risk assessments, and PFMEAs.
• Perform data analysis and support validation studies for clinical phase manufacturing (Phase 1-3).
• Collaborate cross-functionally with manufacturing, quality, and technical operations teams.
• Support regulatory inspections and internal audits during busy periods.
• Ensure validation activities are aligned with current regulatory expectations and industry best practices.

Qualifications

Experience

Additional Requirements

Benefits

Medix Overview :

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we're dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.