Validation Engineer - Pharma Quality & Compliance

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Grand Island, NY seeks a Validation Technician to validate and revalidate equipment and systems per SOPs. You will coordinate testing with affected groups, analyze results, and prepare Final Reports for approval.

Responsibilities include operating chamber qualification equipment, contributing to cGMP-compliant validation programs, supporting deviation investigations and CAPA, and documenting data accurately. BS degree and 1–3 years pharma manufacturing required.

Qualifications

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

Responsibilities

• Validates and revalidates equipment and systems per SOPs.
• Coordinates testing with affected functional groups and evaluates results.
• Prepares Final Reports and circulates for approval.
• Operates instruments for chamber qualifications/requalifications.
• Participates in deviation investigations and CAPA activities.
• Supports improvements to validation programs to stay current with standards.

Skills

Attention to detail

Teamwork

Data analysis

Technical writing

Interpersonal skills

Self-management

Initiative

Education

BS/BA in science, engineering, manufacturing technology or closely related field

Tools

MS Office

Statistical analysis

Job description

Fresenius Kabi in Grand Island, NY seeks a Validation Technician to validate and revalidate equipment and systems per SOPs. You will coordinate testing with affected groups, analyze results, and prepare Final Reports for approval.

Responsibilities include operating chamber qualification equipment, contributing to cGMP-compliant validation programs, supporting deviation investigations and CAPA, and documenting data accurately. BS degree and 1–3 years pharma manufacturing required.