Staff Validation Engineer: 26-03318

Akraya Inc.; 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

Primary Skills: Aseptic processing (advanced), Media fill studies (advanced), cGMP compliance (advanced), Validation protocols (advanced), Risk assessment (intermediate)

Contract Type: W2, Duration: 6 Months, Location: Greenville, NC - 27834 (#LI-Onsite), Pay Range: $60/hr - $66/hr

Job Summary

This role is responsible for leading the design and implementation of media fill studies for aseptic manufacturing operations. You will also be tasked with developing and reviewing critical validation documentation and collaborating with cross-functional teams to ensure regulatory compliance. Additionally, you will contribute to improving contamination control strategies and supporting process investigations.

Key Responsibilities

• 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.

Must-Have Skills

• Extensive experience in aseptic processing.
• Proven track record in pharmaceutical validation.
• Strong understanding of regulatory requirements.
• This role requires significant experience within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing and aseptic processing validation.