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.