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Staff Validation Engineer, Media Fills

Thermo Fisher Scientific
Posted 4 months ago, valid for 8 days
Location

Greenville, NC 27835, US

Salary

Competitive

Contract type

Full Time

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Sonic Summary

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  • The Staff Engineer, Media Fill at Thermo Fisher Scientific will support sterile manufacturing operations by leading media fill programs.
  • Candidates must have a Bachelor's degree in Engineering, Life Sciences, or a related field, along with 8+ years of experience in pharmaceutical or biotech validation.
  • The role requires strong experience in aseptic processing and media fill execution, as well as experience in sterile manufacturing environments.
  • Key responsibilities include authoring validation protocols, ensuring compliance with regulatory standards, and driving continuous improvement initiatives.
  • The position adheres to strict safety and GMP standards, and while salary details are not specified, candidates should be prepared for a professional environment requiring adherence to cleanroom protocols.

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


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