Job Description

Job Summary

We are seeking a highly skilled and detail-oriented Validation Engineer for a 12-month contract role located at our pharmaceutical manufacturing facility in Melrose Park, IL . This position requires working the night shift (10:00 PM to 6:00 AM) .

The ideal candidate will possess robust expertise in technical writing, Standard Operating Procedures (SOPs), and the authoring/execution of rigorous Test Protocols (IQ/OQ/PQ). Experience within a regulated cGMP pharmaceutical environment is mandatory. Exposure to Manufacturing Execution Systems (MES), specifically Werum/Körber PAS-X , is highly preferred.

Key Responsibilities

• Protocol Development & Execution: Draft, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test protocols for pharmaceutical manufacturing equipment, utilities, and automated systems.
• Technical Writing: Author clear, detailed, and highly compliant validation summary reports, deviations, and data analysis summaries in strict accordance with FDA regulations and 21 CFR Part 11.
• SOP Maintenance: Create, revise, and update Standard Operating Procedures (SOPs) to ensure production activities align seamlessly with current validation standards and regulatory policies.
• MES/PAS-X Alignment: Coordinate validation deliverables with the site’s Manufacturing Execution System (MES), leveraging any existing exposure to Werum PAS-X to support Electronic Batch Record (EBR) validation activities and system updates.
• Deviation & CAPA Investigation: Identify, investigate, and document validation protocol deviations and non-conformances occurring during the night shift, conducting root cause analysis and implementing Corrective and Preventive Actions (CAPAs).
• Cross-Functional Collaboration: Partner closely with overnight Operations, Manufacturing, Quality Assurance, and Engineering teams to ensure testing schedules minimize disruption to live production windows.

Required Qualifications

• Education: Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a closely related technical field.
• Experience: 3+ years of experience performing equipment, process, or computerized system validation within a regulated pharmaceutical or biopharmaceutical environment .
• Documentation Mastery: Proven excellence in technical writing with a strong track record of authoring flawless test protocols, validation summaries, and standard operating procedures (SOPs).
• Regulatory Knowledge: Sound understanding of cGMP regulations, GAMP5 guidelines, and data integrity principles.
• Availability: Must be fully committed and flexible to consistently work the designated night shift schedule (10:00 PM to 6:00 AM).

Preferred / Nice-to-Have Qualifications

• Familiarity or slight exposure to Werum/Körber PAS-X MES software.
• Direct experience handling validation changes involving Electronic Batch Records (EBR) or recipe workflows.

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