Cleaning Validation Engineer II

Knowledge & Skills:

• Understanding and application of validation principles, concepts, practices, and industry standards.
• Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
• Familiarity with equipment, utility systems, facility operations, and automation systems.
• Strong investigation and troubleshooting skills.
• Good verbal, written, and interpersonal communication skills.
• Proficient in Microsoft Office applications.

Key Responsibilities:

• Perform validation activities for equipment, utilities, facilities, processes, and/or automation systems in accordance with approved SOPs, cGMPs, and regulatory requirements.
• Lead and execute cleaning validation activities for a multi‑product facility, including parenteral and solid dose products.
• Execute validation protocols and test plans, including sample collection, data recording, and results documentation.
• Compile, analyze, and interpret validation data; prepare validation reports and recommend process improvements.
• Initiate and support investigations and troubleshooting of validation deviations or failures, identifying root cause and corrective actions.
• Coordinate and execute change control activities related to validation, including drafting protocols, reports, and data summaries.
• Maintain comprehensive and compliant validation documentation and records.
• Author and revise validation procedures, protocols, and technical documentation.
• Coordinate and oversee contractors and external resources to ensure timely completion of validation activities.
• Collaborate with cross-functional teams (Manufacturing, Quality, Engineering, etc.) to support project execution.
• Provide day-to-day guidance and training to validation technicians and junior staff as needed.
• Serve as a technical resource for validation-related inquiries from internal teams, contractors, and vendors.
• Resolve moderately complex validation issues with limited supervision while ensuring compliance and data integrity.
• Experience with recovery studies and cleaning validation within GMP-regulated environments
• Hands-on experience with swabbing execution for cleaning verification and monitoring
• Occasionally support night, weekend, and off-shift schedules as needed based on business demands

Basic Qualifications:

• Bachelor’s degree in a science or related field with at least 4 years of relevant experience

OR

• Master’s degree (MS/MBA) with at least 2 years of relevant experience.