QC Cleaning Validation Specialist

QC Cleaning Validation Specialist

About Astellas

At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed groundbreaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide. Learn more at Astellas.com

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

We are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact.

Location and Working Environment

This position is 100% onsite in Tralee, Ireland.

Purpose & 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 implementation of new products, equipment, and process changes; collaborate with Manufacturing and Engineering on process improvements.
• Provide technical expertise, training, and inspection/audit support while maintaining a compliant, inspection-ready cleaning validation programme that supports product quality, patient safety, and contamination control.

Required Qualifications

• B.S. degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab and an Aseptic manufacturing environment.

What awaits you at Astellas?

• Global collaboration and connection with likeminded lifescience leaders.
• Realworld patient impact through transformative therapies.
• Relentless innovation at the forefront of scientific advancement.
• A culture of growth that supports your development and ambitions.

Our Organizational Values and Behaviors

• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

Benefits

Careers | Astellas

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.

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