Sr. Engineer, Cleaning Validation

As a Sr. Engineer in Cleaning Validation, you will develop, maintain, and approve cleaning validation requirements to ensure regulatory compliance. You will shape site cleaning programs from development through lifecycle, guiding procedures, sampling, and education on expectations. You'll interact with regulators and lead validation-related projects to improve effectiveness. This is a chance to influence quality and process excellence in a global pharma environment.

• annual performance bonus
• 401(k) with Hikma match
• paid time off starting at 20 days
• 3 personal days
• 11 company paid holidays
• health, dental, vision, mental health, disability, life insurance

• Develop and approve validation deliverables aligned with regulatory guidelines and business needs
• Represent Cleaning Validation during regulatory inspections
• Periodically review cleaning process compliance to the validated state
• Revise and approve cleaning process procedures and work instructions
• Support optimization and continuous improvement of cleaning processes
• Support training to ensure procedural compliance and process effectiveness
• Create or contribute to validation policies, procedures, guidelines, and templates
• Provide leadership on testing approaches and sampling strategies for new equipment/products
• Lead and mentor Cleaning Validation staff on policies and procedures

• Bachelor's degree in engineering or related scientific discipline
• 8+ years in pharmaceutical quality, production, engineering, or lab settings
• 5+ years in cleaning validation in a pharmaceutical environment
• Knowledge of QA documentation, validation documentation, protocols, and reports
• Strong knowledge of FDA cGMP, ISPE Risk-Based Manufacturing, and ICH Q9
• Experience with FDA/EMA inspections or regulatory interactions
• Problem definition, data analysis, and CAPA planning
• Project management, scheduling, and ability to manage multiple projects
• Excellent written and verbal communication; cross-functional collaboration
• Proficiency with Microsoft Office; knowledge of Change Control, SAP, Document Management systems, or LIMS

• strong communication and interpersonal skills
• leadership and mentoring
• ability to influence and negotiate
• cleaning validation
• validation documentation and technical reports
• QA documentation and protocols