Senior Validation Engineer: Smoke Study & GMP Validation

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

Benefits offered by this job

401(k) contributions

Paid time off

Health benefits

Employee Assistance Program

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a Validation Engineer for an onsite, full-time role in a cGMP pharmaceutical manufacturing environment. The candidate will plan, perform and document validation activities for equipment, facilities and utilities, and coordinate with multi-disciplinary teams to ensure compliance and project success.

The role requires a Bachelor degree in Engineering or a scientific field and at least 3 years in a cGMP facility; strong report writing, GMP knowledge and

Qualifications

• Bachelor degree in Engineering or a scientific field required.
• Minimum 3 years of experience in a cGMP facility; pharmaceutical experience preferred.
• Proficient in generating reports and technical writing.
• Knowledge of cGMPs, industry guidance, and aseptic techniques.

Responsibilities

• Plan, perform and document validation activities for equipment, facilities and utilities in a pharmaceutical manufacturing environment.
• Create validation schedules and coordinate execution with contractors, production operators, manufacturing engineers and QA personnel.
• Track and communicate progress of work against milestones.
• Compose validation plans, protocols, traceability matrices, risk assessments and final report summaries.
• Develops/improves validation programs to remain current with cGMPs and industry standards.
• Represents Validation in teams to specify, install, validate, troubleshoot and maintain systems, equipment and processes.

Education

Bachelor degree in Engineering or a scientific field

Job description

Fresenius Kabi in Melrose Park, IL is seeking a Validation Engineer for an onsite, full-time role in a cGMP pharmaceutical manufacturing environment. The candidate will plan, perform and document validation activities for equipment, facilities and utilities, and coordinate with multi-disciplinary teams to ensure compliance and project success.

The role requires a Bachelor degree in Engineering or a scientific field and at least 3 years in a cGMP facility; strong report writing, GMP knowledge and