Senior Validation Engineer, Aseptic & Media Fill Expert

Modis; Greenville (NC); Presencial; USD 83.000 - 91.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical benefits

Dental benefits

Vision benefits

Life insurance

Short-term disability

401K plan

Resumo da vaga

Modis in Greenville, NC seeks a Staff Validation Engineer to lead aseptic validation initiatives. The role focuses on media fills, aseptic processing, and regulatory-compliant validation documentation, with collaboration across Manufacturing, Quality, and Regulatory teams.

The ideal candidate has 8+ years in pharmaceutical/biotech validation, strong technical writing skills, and proven ability to manage complex validation projects independently, in a GMP environment.

Qualificações

• Bachelors degree in Engineering, Life Sciences, or related field.
• 8+ years of experience in pharmaceutical/biotech validation.
• Strong experience with aseptic processing and media fill execution (required).
• Experience in sterile manufacturing environments (required).
• 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.

Responsabilidades

• 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.

Conhecimentos

Aseptic processing

Media fill execution

Sterile manufacturing

cGMP knowledge

Regulatory expectations

Technical writing

Project leadership

Collaboration

Formação

Bachelor's degree in Engineering or Life Sciences

Descrição da vaga

Modis in Greenville, NC seeks a Staff Validation Engineer to lead aseptic validation initiatives. The role focuses on media fills, aseptic processing, and regulatory-compliant validation documentation, with collaboration across Manufacturing, Quality, and Regulatory teams.

The ideal candidate has 8+ years in pharmaceutical/biotech validation, strong technical writing skills, and proven ability to manage complex validation projects independently, in a GMP environment.