Senior Validation Engineer — Pharma GMP Lead (IQ/OQ/PQ)

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) with company contributions

Health, dental, and vision coverage

Paid vacation and holidays

Employee assistance program

Wellness program

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL, is seeking a Validation Engineer to provide technical support for pharmaceutical manufacturing validation (IQ/OQ/PQ) and lead validation projects in a cGMP facility.

The role requires a bachelor degree in engineering or a scientific field and at least 3 years in a cGMP setting. On-site, full-time with a competitive salary and a bonus target of 6% of base salary; strong writing and data analysis skills are essential.

Qualifications

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

Responsibilities

• Plan, perform and document validation activities for equipment, facilities and utilities (IQ/OQ/PQ).
• Create validation schedules and coordinate with contractors, operators and QA.
• Develop and maintain validation programs to stay current with cGMPs.
• Lead validation projects and write clear reports and summaries.

Skills

Technical writing

Project management

Statistical analysis

English proficiency

Education

Bachelor degree in Engineering or Science

Tools

Microsoft Office

Job description

Fresenius Kabi USA, LLC in Melrose Park, IL, is seeking a Validation Engineer to provide technical support for pharmaceutical manufacturing validation (IQ/OQ/PQ) and lead validation projects in a cGMP facility.

The role requires a bachelor degree in engineering or a scientific field and at least 3 years in a cGMP setting. On-site, full-time with a competitive salary and a bonus target of 6% of base salary; strong writing and data analysis skills are essential.