Staff Validation Engineer, Media Fills

Work Schedule

First Shift (Days)

Environmental Conditions

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

Job Description

How will you make an impact?

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.

What will you do?

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

How will you get here?

Education:

Bachelor’s degree in Engineering, Life Sciences, or related field

Experience:

8+ years of experience in pharmaceutical/biotech validation

Strong experience with aseptic processing and media fill execution (required)

Experience in sterile manufacturing environments (required)

Knowledge, Skills, Abilities:

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