Senior Validation Engineer: Smoke Studies & GMP Validation

Fresenius Kabi USA; Melrose Park (IL); Sur place; USD 80 000 - 100 000; Plein temps

Avantages offerts par ce poste

401(k) with company contributions

Medical insurance

Dental coverage

Vision coverage

Wellness program

Résumé du poste

Fresenius Kabi USA is seeking an experienced Validation Engineer for an on-site, full-time role in Melrose Park, IL. This position requires leading validation projects, writing thorough documents, and ensuring compliance with GMP and ISO standards.

Candidates should hold a bachelor’s degree in engineering or a scientific field and have at least 3 years in a cGMP pharmaceutical setting. Proficiency with IQ/OQ/PQ and statistical analysis is expected.

Qualifications

• Bachelor degree in Engineering or scientific field required.
• Minimum 3 years of relevant cGMP facility experience preferred.
• Proficient in generating reports and technical documents.

Responsabilités

• Independently plan, perform and document validation activities (IQ/OQ/PQ).
• Create validation schedules and coordinate with contractors and QA.
• Develop validation plans, protocols, and risk assessments as needed.
• Represent Validation in cross-functional teams for installation and troubleshooting.

Connaissances

Technical writing

cGMP knowledge

Project management

Statistical analysis

Formation

Bachelor degree in Engineering or Science

Outils

Microsoft Office

Description du poste

Fresenius Kabi USA is seeking an experienced Validation Engineer for an on-site, full-time role in Melrose Park, IL. This position requires leading validation projects, writing thorough documents, and ensuring compliance with GMP and ISO standards.

Candidates should hold a bachelor’s degree in engineering or a scientific field and have at least 3 years in a cGMP pharmaceutical setting. Proficiency with IQ/OQ/PQ and statistical analysis is expected.