Pharma Validation Engineer - Equipment & cGMP

Fresenius Group; Grand Island, Northern (NE, KY); Hybrid; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401K with company contribution

Life insurance

Wellness program

Job summary

Fresenius Kabi in Grand Island, NE seeks a Validation Specialist to verify and revalidate equipment and processes in support of pharmaceutical manufacturing. You will execute qualification studies, analyze data, prepare Final Reports, and support deviations and CAPA as needed.

Strong detail orientation and ability to work in cross-functional teams are essential. Applicants should have a BS/BA in science or engineering, 1–3 years of pharma manufacturing experience, and proficiency with common

Qualifications

• BS/BA in science, engineering, manufacturing technology or related field.
• 1–3 years pharmaceutical manufacturing experience.
• Ability to write clear, concise technical reports and data records.
• Knowledge of cGMPs and aseptic techniques is preferred.

Responsibilities

• Performs equipment requalifications and tests per SOPs with cross‑functional coordination.
• Executes validation studies including protocol, data analysis and Final Report.
• Operates instruments and logs results for regulatory review and audits.
• Participates in deviation investigations and CAPA activities.
• Supports equipment improvements and change-control processes.

Skills

Attention to detail

Proactive

Teamwork

Interpersonal skills

Self-management

Report writing

Statistical awareness

Communication

Education

BS/BA in science or engineering

Equivalent manufacturing experience

Tools

Word

Excel

PowerPoint

Project

Access

Job description

Fresenius Kabi in Grand Island, NE seeks a Validation Specialist to verify and revalidate equipment and processes in support of pharmaceutical manufacturing. You will execute qualification studies, analyze data, prepare Final Reports, and support deviations and CAPA as needed.

Strong detail orientation and ability to work in cross-functional teams are essential. Applicants should have a BS/BA in science or engineering, 1–3 years of pharma manufacturing experience, and proficiency with common