Staff Validation Engineer : 26-03317

Akraya; Greenville (NC); On-site; USD 83,000 - 91,000; Full time

Job summary

Akraya is seeking a skilled Validation Specialist for aseptic manufacturing in Greenville, NC. This onsite role focuses on leading media fill studies and developing critical validation documentation.

You will collaborate with manufacturing, quality, and regulatory teams to ensure cGMP compliance and support process investigations, deviations, and contamination control improvements.

The contract is a 6-month W2 engagement with hourly pay range of $60–$66.

Qualifications

• Extensive experience in aseptic processing.
• Proven track record in pharmaceutical validation.
• Strong understanding of regulatory requirements.

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.

Skills

Aseptic processing

Media fill studies

cGMP compliance

Validation protocols

Risk assessment

Job description

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 (Onsite) Pay Range: $60/hr - $66/hr

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.