Process Validation Engineer – Media Fill

Title: Process Validation Engineer Media Fill
Location: Greenville, NC
Duration: 6 12 Months
Pay Rate: $55 $60/hr W2
Industry: Pharmaceutical / CDMO

Job Description:
Seeking an experienced Process Validation Engineer to support media fill validation and aseptic manufacturing activities within a sterile pharmaceutical manufacturing environment. The ideal candidate will have strong hands-on experience with media fills, aseptic processing, validation execution, and cGMP requirements.

Key Responsibilities:

• Develop, review, and execute media fill validation protocols and reports.
• Coordinate and support Media Fill/Aseptic Process Simulation (APS) studies.
• Support sterile manufacturing and aseptic processing validation activities.
• Perform process and equipment qualification, including IQ/OQ/PQ and PPQ activities.
• Conduct risk assessments and evaluate validation data and results.
• Support validation lifecycle activities, deviations, investigations, and documentation.
• Ensure validation activities comply with cGMP, FDA, global regulatory, and site quality requirements.
• Maintain technically accurate and inspection-ready validation documentation.
• Collaborate with Manufacturing, Engineering, Quality, and other cross-functional teams.

Required Qualifications:

• 5+ years of hands-on media fill validation experience.
• Strong experience with aseptic processing and sterile pharmaceutical manufacturing.
• Experience developing and executing validation protocols and reports.
• Knowledge of process validation, equipment qualification, PPQ, and IQ/OQ/PQ.
• Strong understanding of cGMP, FDA, and pharmaceutical quality requirements.
• Experience with risk assessments, validation documentation, and lifecycle management.