Senior Validation Engineer

Senior Validation Engineer – Cleaning Validation Expert

We are seeking a highly skilled Senior Validation Engineer with pharmaceutical experience, ideally with cleaning validation expertise. The ideal candidate will have a strong background in developing and implementing risk-based cleaning validation strategies, improving current validation processes, and ensuring compliance with regulatory standards. This role is critical in transforming the cleaning validation approach to evaluate new products and equipment against existing worst-case scenarios, enabling a more efficient and compliant validation process.

Key Responsibilities:

• Coordinate cleaning validation activities, including protocol development, execution, and reporting.
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Provide technical support to cleaning activities associated with the manufacturing process.
• Utilize cleaning agents and establish sound cleaning practices in manufacturing and sampling suites.
• Develop and implement risk-based cleaning validation strategies for product transfer and development projects.
• Investigate and conduct root cause analysis for cleaning-related deviations, incidents, and out-of-specification results.
• Lead enhancements in clean-in-place (CIP) equipment and cleaning methodologies.
• Review and approve Manufacturing Cleaning Working Instructions and Forms.
• Support periodic reviews of cleaning validation studies and ensure compliance with industry standards.
• Resolve incidents and deviations related to cleaning validation exercises in a timely manner.
• Issue Change Controls for implementing cleaning procedure modifications.
• Train manufacturing, QC, and QA personnel on cleaning validation documentation and procedures.

Qualifications and Skills:

• Bachelor's or Master's Degree in Science, Pharmacy, or Engineering.

• Minimum 5 years of experience in cleaning validation within the pharmaceutical or biotechnology industries.

• Strong knowledge of cleaning validation, process improvement, and troubleshooting methodologies.

• Hands-on experience with mixing solutions (formulations).

• Project management expertise with excellent time management and organizational skills.

• Demonstrated leadership, teamwork, and ability to collaborate across multiple departments.

• Proficiency in Risk Assessment/Management and developing risk-based validation strategies.

• Strong analytical, problem-solving, and root cause analysis skills.

• Excellent presentation, technical writing, and oral communication skills.

• Thorough understanding of cGMPs, FDA regulations, OSHA standards, and industry best practices.

Additional Considerations:

• Experience leading significant process changes and implementing new validation methodologies.

• Ability to work independently while driving projects and ensuring compliance.

• Local candidates only—onsite interview required in Mount Prospect, IL.