Sr. Validation Engineer

Sterling Engineering
Kankakee, IL

Location: Kankakee, IL

Title: Sr. Validation Engineer – Aseptic / Sterile Manufacturing

Contract Length: 12+ Months

Experience: ~10 Years

Work Type: Full-time, Onsite

Travel: Local preferred; must be open to occasional travel

Overview

Seeking an experienced Validation Engineer to support day-to-day validation activities within an aseptic/sterile manufacturing environment.

Key Responsibilities

• Provide daily support to site validation team across ongoing manufacturing operations

• Execute validation activities within aseptic liquid processing environments

• Support commissioning, qualification, and validation (CQV) efforts for GMP systems and equipment

• Assist with protocol execution and documentation (IQ/OQ/PQ as applicable)

• Partner with QA, Engineering, and Operations to ensure compliance with cGMP standards

• Support deviation investigations, change controls, and revalidation efforts as needed

• Maintain accurate and compliant validation documentation

Requirements

• ~10 years of validation experience in pharmaceutical or biotech environments

• Strong experience in aseptic/sterile liquid manufacturing

• Hands-on CQV experience (equipment, utilities, or processes)

• Working knowledge of cGMP regulations and validation lifecycle

• Ability to operate independently in a fast-paced manufacturing environment

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