Job Title: Validation Engineer (Cleaning Validation)

Work Location: Monroe County, Indiana

Summary:

Seeking a Validation Engineer specializing in cleaning validation to support a cGMP sterile manufacturing facility. This contract role requires strong technical knowledge, independence, and excellent communication skills to ensure compliance and effectiveness of cleaning processes for manufacturing equipment.

Responsibilities:

• Develop, execute, and maintain cleaning validation programs for sterile manufacturing operations.
• Ensure cleaning processes for product-contact equipment such as autoclaves, sterilizers, filling lines, and process tanks meet regulatory standards.
• Design and oversee swab and rinse sampling studies, including method validation and recovery studies.
• Support cleaning validation activities for both portable and stationary tanks, mixing vessels, and associated piping systems.
• Coordinate and validate cleaning of filling lines, autoclaves, and sterilizers, integrating with related validation activities as needed.
• Work independently to submit cleaning validation samples to laboratories and interpret analytical results.
• Collaborate with quality control laboratories to coordinate analytical testing such as TOC, conductivity, HPLC, bioburden, and endotoxin.
• Demonstrate strong attention to detail and proactive problem-solving in a fast-paced, regulated environment.

Qualifications:

• Bachelor’s or Associate’s degree preferred, but not required.
• 5–7 years of validation experience in a cGMP pharmaceutical, biotech, or medical device manufacturing environment, with a focus on cleaning validation.
• Hands-on experience with cleaning validation for sterile/aseptic manufacturing equipment, including autoclaves, sterilizers, and filling lines.
• Strong technical knowledge of cleaning validation principles and regulatory requirements.
• Excellent communication skills and ability to work independently with minimal supervision.
• Demonstrated attention to detail and organizational skills.
• Ability to coordinate with laboratory and quality teams for analytical testing and data interpretation.
• Proactive, self-motivated, and able to manage multiple priorities in a dynamic environment.

Published Category: Quality & Validation