Pharma Validation Engineer — Quality, Compliance & Impact

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

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) with company match

Wellness program

Job summary

Fresenius Kabi USA in Grand Island, NY seeks a Validation Specialist to verify new or modified products, equipment or systems and support Operations with initial validation and requalification activities.

You will perform equipment requalifications, validate studies, and operate instruments to ensure compliant testing and reporting, while contributing to continuous improvement of validation programs and quality systems.

Qualifications

• BS/BA in science, engineering, manufacturing technology or closely related field, or equivalent experience.
• 1–3 years pharmaceutical manufacturing experience.
• Excellent attention to detail.
• Must be proactive, able to work in high performance teams, strong interpersonal and self-management skills.
• Ability to write reports, deviations or other technical documents clearly and accurately; basic statistical understanding.
• English language proficiency required for policies and communications.

Responsibilities

• Performs equipment requalifications per SOPs and communicates testing results to affected groups.
• Executes validation studies, including protocol prep, scheduling, data analysis and final report circulation.
• Programs and operates analytical instruments for chamber qualifications/requalifications.
• Contributes to improvements of validation programs to stay current with cGMPs.
• Participates in deviation investigations and CAPA activities.
• Supports regulatory presentations when needed.

Skills

Attention to detail

Proactive

Team collaboration

Written communication

Statistical analysis

Education

BS/BA in science or related field

Tools

Word

Excel

PowerPoint

Project

Access

Job description

Fresenius Kabi USA in Grand Island, NY seeks a Validation Specialist to verify new or modified products, equipment or systems and support Operations with initial validation and requalification activities.

You will perform equipment requalifications, validate studies, and operate instruments to ensure compliant testing and reporting, while contributing to continuous improvement of validation programs and quality systems.