Staff Validation Engineer, Media Fills
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职位描述
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
公司 · Company
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