Facility Validation Engineer

Job Title: Facility Validation Engineer

Location: North Chicago, IL Duration: Full-time (Contract/Permanent – confirm with hiring team)

Role Overview

Seeking a Facility Validation Engineer to provide technical support to Engineering and Validation teams. This role involves preparing qualification protocols, executing commissioning and validation studies, and producing concise, accurate reports. A foundational understanding of cGMP is essential.

Key Responsibilities

Utility & Facility Commissioning : Support commissioning and validation of utilities and new equipment alongside Engineering.

Validation Protocols & Execution : Lead qualification studies (utility, equipment, cleaning, facility, process computer) — risk assessments, protocols, scheduling, execution, and final reporting.

Cross‑Functional Representation : Act as Technical Services liaison in teams specifying, installing, validating, and maintaining systems and equipment.

Deviation Management : Manage multiple deviation investigations, ensuring validation timelines remain unaffected.

Process Improvement : Collaborate with process experts and production personnel to identify and implement technical optimizations.

Reporting & Documentation : Use Word, Excel, Documentum, and other systems to draft validation documents and reports.

Compliance & Safety : Adhere to company policies, training requirements, cGMPs, and safety standards.

Additional Duties : Perform tasks as assigned by Management to support team objectives.

Qualifications

• Education : Bachelor’s degree in Science or Engineering (or equivalent work experience).

• Experience : 3–5 years in a GMP manufacturing environment, focusing on utilities and facility qualification. Familiarity with FDA regulatory requirements is required.

• Technical & Critical Thinking : Strong critical thinking skills and proven ability to write clear, articulate technical documentation.

• Organizational Skills : Excellent time management and ability to prioritize multiple concurrent tasks.

• Communication : Strong interpersonal abilities and team collaboration skills.

• This is an excellent opportunity for a detail-oriented engineer with a GMP background to support critical validation efforts in a dynamic manufacturing environment.

• Interested candidates —please share your resume and availability.