Senior Validation Engineer - GMP IQ/OQ/PQ Leader

Socket.dev; Melrose Park (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health, dental, vision coverage

Job summary

Fresenius Kabi is seeking a Validation Engineer to oversee IQ/OQ/PQ validation for manufacturing equipment, facilities, and utilities in a cGMP environment. The role requires strong documentation, reporting, and project management skills, with on-site, full-time engagement.

The candidate will lead validation projects, develop protocols and reports, and participate in continuous improvement while ensuring compliance with Health, Safety, Environment, Energy and Quality Management Systems.

Qualifications

• Proficient in generating reports and technical writing/reviewing skills required.
• Ability to prepare clear, concise technical documents and reports.
• Experience with documenting validation activities and results.

Responsibilities

• Plan, perform 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 communicate status.
• Develop validation plans, protocols, traceability matrices and final reports.
• Improve validation programs to remain current with cGMPs and standards.
• Lead validation projects and manage time effectively.
• Support energy management system and continuous improvement efforts.

Skills

Technical writing

Reporting

Documentation

Education

Bachelor degree in Engineering or a Scientific Field

Tools

Microsoft Office

Job description

Fresenius Kabi is seeking a Validation Engineer to oversee IQ/OQ/PQ validation for manufacturing equipment, facilities, and utilities in a cGMP environment. The role requires strong documentation, reporting, and project management skills, with on-site, full-time engagement.

The candidate will lead validation projects, develop protocols and reports, and participate in continuous improvement while ensuring compliance with Health, Safety, Environment, Energy and Quality Management Systems.