Pharma Validation Engineer: cGMP Quality & Compliance

Fresenius SE & Co. KGaA; Grand Island, Northern (NE, KY); Hybrid; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Grand Island, Nebraska, seeks a Validation Specialist to support qualification activities, equipment testing, and technical support for Operations. You will validate and revalidate systems, document results, and ensure cGMP compliance.

The role involves programming instruments, executing validation studies, preparing Final Reports, and assisting in deviation investigations. Strong attention to detail and teamwork are essential.

Qualifications

• BS/BA degree or equivalent experience in science, engineering, manufacturing.
• 1–3 years pharmaceutical manufacturing experience.
• Excellent attention to detail.
• Proactive with strong teamwork and communication.
• Ability to write clear technical reports and document data.
• Proficient with MS Office and data handling.

Responsibilities

• Performs equipment requalifications per SOPs and coordinates testing with functional groups.
• Executes equipment validation studies from protocol to Final Report and approval.
• Programs and operates analytical instruments for chamber qualifications/requalifications.
• Participates in improvements to validation programs to stay current with cGMPs.
• Contributes to deviation investigations and CAPAs.
• Performs HEPA/airflow testing and records results.
• Supports regulatory presentations when needed.
• Engages in equipment improvement to ensure compliance and performance.

Skills

Detail oriented

Team collaboration

Documentation writing

Statistical analysis basics

PC literacy

cGMP knowledge

Education

BS/BA in science or engineering

Tools

Excel

Word

PowerPoint

Project

Access

Job description

Fresenius Kabi in Grand Island, Nebraska, seeks a Validation Specialist to support qualification activities, equipment testing, and technical support for Operations. You will validate and revalidate systems, document results, and ensure cGMP compliance.

The role involves programming instruments, executing validation studies, preparing Final Reports, and assisting in deviation investigations. Strong attention to detail and teamwork are essential.