Staff Validation Engineer, Media Fills

Thermo Fisher Scientific • Greenville, NC

1d

About The Position

The Staff Engineer, Media Fill plays a critical role in supporting sterile and aseptic manufacturing operations by leading media fill (aseptic process simulation) programs. This role ensures processes remain in a validated state and comply with global regulatory expectations.

The position leads the design and execution of media fill studies, prepares and reviews validation documentation, supports investigations and corrective actions, collaborates across functional teams, and drives continuous improvement in validation and contamination control strategies.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 8+ years of experience in pharmaceutical or biotech validation.
• Strong experience with aseptic processing and media fill execution.
• Experience in sterile manufacturing environments.
• Deep understanding of aseptic processing and contamination control.
• Strong knowledge of cGMP and regulatory expectations.
• Technical writing expertise in validation protocols and reports.
• Ability to lead complex validation projects independently.
• Strong collaboration and communication skills.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior