Hiring for Process Validation Engineer - Greenville, NC (Onsite)

Hope you're doing well.

This is Satya from United Pharma Technologies Inc. We have an immediate opportunity with one of our pharmaceutical clients for a Process Validation Engineer in Greenville, NC.

Position: Process Validation Engineer
Location: Greenville, NC Onsite

Key Responsibilities:

• Lead and execute Process Performance Qualification (PPQ) activities.
• Support validation activities for a new aseptic fill-finish manufacturing line.
• Coordinate and execute aseptic media fill studies.
• Support revalidation activities for pre-filled syringe (PFS) filling operations.
• Support technology transfer activities for new products and manufacturing processes.
• Perform risk assessments and author/review validation protocols and reports.
• Support smoke studies, Automated Visual Inspection (AVI) qualification, and equipment qualification.
• Investigate validation and aseptic-processing issues and support deviation resolution.
• Work closely with clients, Manufacturing, Engineering, Quality, and Validation teams throughout tech transfer and PPQ execution.

Required Experience:

• Strong hands-on Process Validation experience.
• Strong experience with PPQ execution.
• Hands-on Tech Transfer experience.
• Experience in sterile/aseptic fill-finish manufacturing.
• Experience with PFS filling lines is highly preferred.
• Strong execution background in a GMP pharmaceutical environment.
• Experience with media fills, equipment qualification, smoke studies, and/or AVI is highly desirable.