Senior Validation Engineer

ABOUT THE JOB

• Plan and execute cleaning validation and process validation activities
• Prepare and review validation protocols, reports, and supporting documentation
• Define validation approaches, acceptance criteria, and sampling plans in collaboration with relevant technical and quality teams
• Coordinate validation execution, including sampling, testing, and documentation activities
• Review and assess validation results against established acceptance criteria
• Investigate validation deviations and support root-cause analysis and corrective and preventive actions (CAPAs)
• Assess the impact of changes on validated processes and cleaning procedures
• Provide technical guidance on validation activities and support the resolution of validation issues
• Ensure validation documentation is complete, accurate, and compliant with applicable site procedures and GMP requirements

ABOUT YOU

• Diploma or Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biotechnology, or a related discipline
• At least 5 years of experience in validation within pharmaceutical or biotechnology environments, with experience in both cleaning validation and process validation
• Experience preparing, executing, and reviewing validation protocols and reports
• Knowledge of cleaning validation principles, including residue limits, sampling approaches, and acceptance criteria
• Understanding of process validation principles and the maintenance of a validated state
• Experience supporting deviations, CAPAs, and change-control activities
• Ability to coordinate validation activities and provide technical guidance to cross-functional teams
• Strong analytical, problem-solving, communication, and documentation skills
• Fluent in English, both written and spoken