Pharma Quality Engineer: QA, Validation & Compliance

Fresenius; Melrose Park (IL); Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) with company contribution

Job summary

Fresenius Kabi in Melrose Park, IL, is seeking a quality assurance professional to ensure integrated fill line facilities and processes meet regulatory and company standards. You will oversee validation, metrology, and qualification activities in collaboration with manufacturing, engineering, and quality teams.

The role requires a B.S. in a technical science and 3 years in a regulated pharma setting, with experience in change control, cGMP, and software validation.

Qualifications

• B.S. degree in a technical science is required.
• 3 years of experience in a highly regulated industry, preferably pharmaceutical.
• Experience with Change Control is strongly preferred.
• Working knowledge of cGMPs, FDA guidelines, and ISO standards is preferred.

Responsibilities

• Oversees ECRs for integrated fill lines including pre- and post-approval changes.
• Supports plant operations during runs and maintenance shutdowns, including off-shift.
• Provides QA oversight for software validation, equipment qualification, and commissioning.
• Analyzes data, conducts root cause investigations and implements corrective actions.
• Reviews batch records and documents to ensure timely production and release.

Skills

Quality assurance

Regulatory compliance

Root cause analysis

Risk assessment

Education

B.S. degree in technical science

Tools

Trackwise

SAP

eDMS

Job description

Fresenius Kabi in Melrose Park, IL, is seeking a quality assurance professional to ensure integrated fill line facilities and processes meet regulatory and company standards. You will oversee validation, metrology, and qualification activities in collaboration with manufacturing, engineering, and quality teams.

The role requires a B.S. in a technical science and 3 years in a regulated pharma setting, with experience in change control, cGMP, and software validation.