QC Cleaning Validation Specialist

QC Cleaning Validation Specialist

Description

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• About Astellas

• Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

• Are you driven to make a real difference in the lives of patients?

• We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

• Working Environment and Location

• This position is 100% onsite in Tralee, Ireland.

• Purpose and Scope

• The QC Cleaning Validation Specialist is responsible for providing technical and quality oversight for cleaning validation activities to ensure that equipment, facilities, and manufacturing processes consistently meet established regulatory, quality, and operational requirements. The role supports the development, execution, review, and lifecycle management of cleaning validation programs, ensuring compliance with current GMP regulations, industry standards, and site procedures while safeguarding product quality, patient safety, and data integrity.

• The QC Cleaning Validation Specialist supports cross-functional teams including but not limited to Quality Assurance, Manufacturing, Engineering, Validation, and Regulatory Affairs in the planning, execution, and maintenance of cleaning validation activities. Responsibilities include risk assessments, sampling strategy development, analytical method support, residue limit calculations, protocol and report review, investigation of cleaning validation deviations, trending of cleaning verification data, and continuous improvement initiatives. The role applies to all GMP manufacturing equipment, product contact surfaces, cleaning processes, and associated analytical testing performed within the facility and supports regulatory inspections, audits, and compliance activities.

• Role and Responsibilities

• Develop, review, and approve cleaning validation/verification protocols, reports, risk assessments, and controlled documentation in line with GMP, Data Integrity, EHS, and QMS requirements.

• Establish scientifically justified residue limits, acceptance criteria, and risk-based sampling strategies using toxicological, pharmacological, analytical, and regulatory principles.

• Support analytical method development/validation and execute QC laboratory testing required for cleaning validation activities.

• Review, trend, and assess cleaning validation data; lead investigations into failures, deviations, OOS results, CAPAs, and atypical findings, ensuring timely closure.

• Maintain the validated state through lifecycle management, continued verification, change assessments, and implement