Lead Aseptic Validation Engineer - Media Fill Expert Onsite

Akraya; Greenville (NC); In loco; USD 83.000 - 91.000; Tempo pieno

Descrizione del lavoro

Akraya in Greenville, NC is seeking a dedicated professional to lead the design and execution of media fill studies for aseptic manufacturing, while developing and reviewing validation documentation to ensure regulatory compliance. You will help enhance contamination control strategies and investigate deviations with cross-functional teams.

The role requires extensive aseptic processing experience and a strong track record in pharmaceutical validation, with a focus on sterile manufacturing and

Competenze

• Extensive experience in aseptic processing.
• Proven track record in pharmaceutical validation.
• Strong understanding of regulatory requirements.
• Experience in sterile manufacturing and aseptic validation within pharma/biotech.

Mansioni

• Lead media fill study design and execution for aseptic processes.
• Author and review validation protocols, reports, and risk assessments.
• Support investigations and deviations for aseptic manufacturing.
• Collaborate with manufacturing, quality, and regulatory departments.
• Drive improvements in validation and contamination control.

Conoscenze

Aseptic processing

Media fill studies

cGMP compliance

Validation protocols

Risk assessment

Descrizione del lavoro

Akraya in Greenville, NC is seeking a dedicated professional to lead the design and execution of media fill studies for aseptic manufacturing, while developing and reviewing validation documentation to ensure regulatory compliance. You will help enhance contamination control strategies and investigate deviations with cross-functional teams.

The role requires extensive aseptic processing experience and a strong track record in pharmaceutical validation, with a focus on sterile manufacturing and