Validation Engineer - Onsite Role: Elevate cGMP Compliance

Socket.dev; Melrose Park (IL); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

401K with company contributions

Health benefits (medical, dental, visn

Paid vacation

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL seeks a Validation Engineer to support equipment, process, and cleaning validation on-site. You will plan and execute qualification activities, create protocols, and present results for regulatory review.

Requirements include a Bachelor's degree in science or engineering and at least one year in a cGMP environment. The role requires flexibility for occasional off-shift hours; salary ranges from $65,000 to $80,000 with comprehensive benefits and bonus

Qualifications

• Bachelor’s degree in Science or Engineering required.
• Minimum of one year relevant work experience in a cGMP regulated industry.
• Experience generating reports, deviations or other technical documents.

Responsibilities

• Schedules and executes equipment requalifications per SOPs.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Assembles and composes the final report and circulates for approval.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) with protocol preparation and final report.

Skills

Analytical thinking

Report writing

Quality systems understanding

Education

Bachelor's degree in Science or Engineering

Tools

Datalogger programming

SOP execution

Job description

Fresenius Kabi in Melrose Park, IL seeks a Validation Engineer to support equipment, process, and cleaning validation on-site. You will plan and execute qualification activities, create protocols, and present results for regulatory review.

Requirements include a Bachelor's degree in science or engineering and at least one year in a cGMP environment. The role requires flexibility for occasional off-shift hours; salary ranges from $65,000 to $80,000 with comprehensive benefits and bonus