QC Cleaning Validation Specialist (IE)

Biopharma Careers; Ireland; On-site; EUR 60,000 - 80,000; Full time

Job summary

Astellas is seeking a QC Cleaning Validation Specialist for 100% onsite work in Tralee, Ireland. The role focuses on validation activities to ensure equipment, facilities, and processes meet regulatory and quality requirements.

You will support method development/validation, risk-based sampling, and investigations into deviations while maintaining lifecycle validated state and ensuring data integrity and patient safety.

Qualifications

• 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.

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.

Skills

Quality Control

Analytical testing

GMP compliance

Risk assessment

Education

B.S. in Chemistry/Microbiology

Tools

Analytical methods

Documentation control

Job description

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 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.

Essential Qualifications

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

Benefits

Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours

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

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.