Pharma Equipment Validation Engineer

Fresenius Kabi USA, LLC; Town of Grand Island (NY); On-site; USD 61,000 - 86,000; Full time

Job summary

Fresenius Kabi USA, LLC in New York is seeking a Validation Specialist to validate and revalidate products, equipment and systems, and to provide technical support to Operations.

This role conducts equipment qualification studies, analyzes data, prepares final reports, and participates in deviations and CAPA processes, ensuring cGMP compliance and readiness for regulatory filings as needed.

Qualifications

• BS/BA degree in science, engineering, manufacturing technology or closely related field
• 1–3 years pharmaceutical manufacturing experience
• Excellent attention to detail
• Proactive with strong teamwork and interpersonal skills
• Ability to write clear reports and basic statistical analysis
• PC literate with standard office applications (Word, Excel, PowerPoint) and knowledge of cGMPs

Responsibilities

• Performs equipment requalifications per SOPs and communicates results to affected groups
• Executes equipment validation studies from protocol through Final Report
• Programs and operates analytical instruments for chamber qualifications/requalifications
• Participates in improvement of validation programs and regulatory compliance
• Participates in deviation investigations and CAPA actions
• Conducts HEPA/critical area testing and records results
• Participates in presentations to Regulatory Agencies when needed
• Contributes to equipment improvement teams to enhance compliance and performance

Skills

Attention to detail

Proactive

Teamwork

Interpersonal skills

Self-management

Report writing

Data analysis

Office software

Education

BS/BA in science/engineering

Tools

Office suite (Word, Excel, PowerPoint)

Job description

Fresenius Kabi USA, LLC in New York is seeking a Validation Specialist to validate and revalidate products, equipment and systems, and to provide technical support to Operations.

This role conducts equipment qualification studies, analyzes data, prepares final reports, and participates in deviations and CAPA processes, ensuring cGMP compliance and readiness for regulatory filings as needed.