Onsite Computer Systems Validation Engineer — cGMP Focus

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

401(k) contributions

Health benefits

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a Validation Engineer to specialize in computerized systems validation within a cGMP facility. The role involves creating and executing qualification protocols for MES, historian, and other manufacturing apps, with strong interaction across departments.

The engineer will prepare final reports, support regulatory interactions, and contribute to validation master and project plans. Onsite, full-time position with comprehensive benefits and growth opportunities.

Qualifications

• Bachelor’s Degree in a Science or Engineering field is required.
• Minimum 1 year of related experience in a cGMP facility with FDA regulations.
• Excellent technical writing and verbal communication skills.
• Experience negotiating and working with cross-functional teams.
• Understanding of MES(EBR), historian, OEE, and other manufacturing applications.
• Proficiency with Word, Excel, PowerPoint, Project, Access.

Responsibilities

• Schedule and execute computer system qualifications per SOPs.
• Coordinate and communicate testing with affected groups and evaluate results.
• Assemble and finalize reports for approval.
• Conduct validation studies including protocol prep, scheduling, execution, and final reports.
• Present results to Regulatory Agencies when needed.
• Develop and update validation documents (URS, FDS, DS, risk assessments, FMEAs).
• Provide technical support for Investigations, Change Controls and Risk Assessments.

Skills

Technical writing

Verbal communication

Negotiation

Leadership

Communication

Judgment

Decision making

Problem solving

Multitasking

Independence

Adaptability

cGMP knowledge

Office software

Education

Bachelor’s Degree in a Science or Engineering field

Tools

MS Office

Job description

Fresenius Kabi USA, LLC is seeking a Validation Engineer to specialize in computerized systems validation within a cGMP facility. The role involves creating and executing qualification protocols for MES, historian, and other manufacturing apps, with strong interaction across departments.

The engineer will prepare final reports, support regulatory interactions, and contribute to validation master and project plans. Onsite, full-time position with comprehensive benefits and growth opportunities.