Pharma Validation Engineer — cGMP Impact & Growth

Fresenius; Grand Island (NE); On-site; USD 63,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with company contributions

Wellness program

Job summary

Fresenius Kabi is seeking a Validation Specialist to validate and revalidate new or modified products, equipment or systems in our manufacturing environment. You will support Operations with equipment/system initial validation and requalifications, ensuring compliance with cGMPs and industry standards.

You will lead protocol development, data analysis, Final Report preparation and coordination with cross-functional teams.

Qualifications

• BS/BA in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
• 1–3 years pharmaceutical manufacturing experience.
• Excellent attention to detail.

Responsibilities

• Performs equipment requalifications per SOPs, coordinates testing with affected functional groups, evaluates results and circulates Final Report for approval.
• Executes equipment validation studies per SOPs, including protocol prep, scheduling, execution, data analysis and Final Report.
• Programs and operates department analytical instruments for chamber qualifications/requalifications (e.g., lyophilizers, sterilizers, depyrogenation ovens/tunnels).
• Participates in improvements to validation programs to stay current with cGMPs and industry standards.
• Participates in teams to validate and maintain systems and equipment.
• Participates in deviation investigations and corrective/preventive actions.

Skills

Attention to detail

Teamwork

Communication

Education

BS/BA in science or engineering

Tools

MS Office

Job description

Fresenius Kabi is seeking a Validation Specialist to validate and revalidate new or modified products, equipment or systems in our manufacturing environment. You will support Operations with equipment/system initial validation and requalifications, ensuring compliance with cGMPs and industry standards.

You will lead protocol development, data analysis, Final Report preparation and coordination with cross-functional teams.