Senior Validation Engineer - Aseptic Media Fill Lead

Modis; Greenville (NC); On-site; USD 69,000 - 91,000; Full time

Job summary

Modis is seeking a Staff Validation Engineer for a contract position to lead validation activities in a pharmaceutical manufacturing setting with a focus on aseptic processing and sterile manufacturing.

Responsibilities include designing and executing APS studies, developing validation documentation, and collaborating with QA, regulatory, and manufacturing teams to ensure compliance with cGMP and global requirements.

Qualifications

• 8+ years of experience in pharmaceutical or biotechnology validation.
• Strong hands-on experience with Media Fill / Aseptic Process Simulation (APS).
• Experience with sterile pharmaceutical manufacturing environments and cGMP regulatory requirements.

Responsibilities

• Lead the design, planning, and execution of Media Fill studies for aseptic manufacturing processes.
• Develop, review, and approve validation protocols, reports, and risk assessments.
• Support investigations, deviations, and CAPA activities related to media fills and aseptic manufacturing.

Skills

Media Fill

Aseptic Processing

Validation Leadership

Education

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

Job description

Modis is seeking a Staff Validation Engineer for a contract position to lead validation activities in a pharmaceutical manufacturing setting with a focus on aseptic processing and sterile manufacturing.

Responsibilities include designing and executing APS studies, developing validation documentation, and collaborating with QA, regulatory, and manufacturing teams to ensure compliance with cGMP and global requirements.