Pharma Validation Engineer - GMP Equipment & Systems

Fresenius Kabi USA; Town of Grand Island (NY); On-site; USD 63,000 - 85,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Dental coverage

Vision coverage

Paid vacation

Life insurance

Disability

Wellness program

Job summary

Fresenius Kabi USA is seeking a detail‑oriented professional to validate and revalidate new or modified products, equipment, or systems. You will support Operations with equipment initial validation and requalification, and coordinate testing across functional teams, documenting findings and Final Reports.

The role requires a BS/BA in science or engineering and 1–3 years of pharmaceutical manufacturing experience, with strong data analysis, technical writing, and teamwork skills.

Qualifications

• BS/BA in science, engineering, or closely related field.
• 1–3 years pharmaceutical manufacturing experience.
• Strong attention to detail and ability to work in cross-functional teams.

Responsibilities

• Perform equipment requalifications per SOPs and communicate results to affected groups.
• Execute equipment validation studies including protocol prep, execution, data analysis and Final Report circulation.
• Operate and program analytical instruments and data loggers for chamber qualifications/requalifications.
• Participate in deviations investigations and CAPA activities; support change control.
• Assist in improvements to validation programs to stay current with cGMPs and industry standards.

Skills

Pharma manufacturing

cGMPs knowledge

Data analysis

Technical writing

Team collaboration

Education

BS/BA in science or engineering

Tools

Data analysis software

Job description

Fresenius Kabi USA is seeking a detail‑oriented professional to validate and revalidate new or modified products, equipment, or systems. You will support Operations with equipment initial validation and requalification, and coordinate testing across functional teams, documenting findings and Final Reports.

The role requires a BS/BA in science or engineering and 1–3 years of pharmaceutical manufacturing experience, with strong data analysis, technical writing, and teamwork skills.