Senior Validation Engineer - Onsite GMP IQ/OQ/PQ Leader

Fresenius SE & Co. KGaA; Melrose Park, Northern (IL, KY); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation and personal days

Medical, dental, vision coverage

Job summary

Fresenius Kabi in Melrose Park, IL seeks a Validation Specialist to lead equipment and facility validation programs. You will manage IQ/OQ/PQ efforts, coordinate with production, QA, and engineers, and ensure compliant documentation and timelines.

Requirements include a engineering/science degree and 3+ years in a cGMP setting. Onsite, full-time role with a strong focus on ISO/GMP standards and continuous improvement.

Qualifications

• Bachelor degree in Engineering or a scientific field is required.
• Minimum 3 years in a cGMP facility; pharma experience preferred.
• Proficient in reports and technical documents; strong writing skills.

Responsibilities

• Independently plan and document validation activities (IQ, OQ, PQ) for equipment, facilities and utilities.
• Create validation schedules and coordinate with contractors, operators and QA.
• Track progress against milestones and write validation plans, protocols and reports.
• Improve validation programs to stay current with cGMPs and industry standards.
• Represent Validation in cross-functional teams and support regulatory readiness.

Skills

Project management

Technical writing

Statistical analysis

GMP knowledge

Education

Bachelor degree in Engineering or a Scientific Field

Tools

Microsoft Office

Job description

Fresenius Kabi in Melrose Park, IL seeks a Validation Specialist to lead equipment and facility validation programs. You will manage IQ/OQ/PQ efforts, coordinate with production, QA, and engineers, and ensure compliant documentation and timelines.

Requirements include a engineering/science degree and 3+ years in a cGMP setting. Onsite, full-time role with a strong focus on ISO/GMP standards and continuous improvement.