Staff Validation Engineer, Media Fills

Schedule

First Shift (Days)

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards
• Cleanroom requirements: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed
• Personal Protective Equipment (PPE) required: safety glasses, gowning, gloves, lab coat, ear plugs, etc.

About the Role

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. The Staff Engineer, Media Fill plays a critical role in supporting sterile/aseptic manufacturing operations by leading media fill (aseptic process simulation) programs. This role ensures processes remain in a validated state and compliant with global regulatory expectations.

Responsibilities

• Lead the design and execution of media fill (APS) studies for aseptic manufacturing processes
• Author and review validation protocols, reports, and risk assessments
• Support investigations, deviations, and CAPAs related to media fills and aseptic processes
• Partner cross-functionally with Manufacturing, Quality, and Regulatory teams
• Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements
• Drive continuous improvement initiatives in validation and contamination control strategies

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 8+ years of experience in pharmaceutical/biotech validation
• Strong experience with aseptic processing and media fill execution (required)
• Experience in sterile manufacturing environments (required)

Skills

• Deep understanding of aseptic processing and contamination control
• Strong knowledge of cGMP and regulatory expectations
• Technical writing expertise (validation protocols and reports)
• Ability to lead complex validation projects independently
• Strong collaboration and communication skills