Lead Aseptic Validation Engineer – Media Fill Expert

Experis Technology Group

Greenville (NC)

On-site

USD 57,000 - 81,000

Full time

2 days ago
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Benefits offered by this job

Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account
Health Flexible Spending Account
Dependent Care Flexible Spending Array
Supplemental Life Insurance
Short Term and Long Term Disability
Business Travel Insurance
401(k), Plus Match
Weekly Pay

Job summary

Our client in the pharmaceutical/biotech sector is seeking a Staff Validation Engineer to join the Validation and Quality organization in Greenville, NC. You will lead aseptic validation initiatives and contribute to contamination control programs, ensuring compliance with cGMP and global regulatory expectations.

The role emphasizes technical leadership, cross-functional collaboration, and clear communication to advance sterile manufacturing readiness and patient safety in a fast-paced

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • 8+ years of pharmaceutical/biotech validation experience.
  • Strong aseptic processing and media fill execution experience; sterile manufacturing familiarity; strong technical writing.

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.
  • Drive continuous improvement in validation and contamination control while ensuring compliance with cGMP and regulatory expectations.

Skills

Aseptic processing
Media fill execution
Technical writing
Cross-functional leadership
cGMP compliance

Education

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

Job description

Our client in the pharmaceutical/biotech sector is seeking a Staff Validation Engineer to join the Validation and Quality organization in Greenville, NC. You will lead aseptic validation initiatives and contribute to contamination control programs, ensuring compliance with cGMP and global regulatory expectations.

The role emphasizes technical leadership, cross-functional collaboration, and clear communication to advance sterile manufacturing readiness and patient safety in a fast-paced

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