QC Cleaning Validation Specialist

Astellas Pharma; Tralee; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Global collaboration

Real-world patient impact

Relentless innovation

Culture of growth

Job summary

Astellas in Tralee, Ireland seeks a QC Cleaning Validation Specialist onsite to lead validation activities, risk assessments, and data integrity efforts. You will collaborate with QA, Manufacturing, and Regulatory to ensure compliant cleaning validation programs across GMP manufacturing operations.

The role requires a B.S. in Chemistry or Microbiology with relevant QC lab and aseptic experience; you will maintain lifecycle validation, support investigations, and contribute to continuous

Qualifications

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

Responsibilities

• Develop, review, and approve cleaning validation/verification protocols, reports, risk assessments, and documentation per GMP and QMS requirements.
• Set scientifically justified residue limits and sampling strategies using toxicological and regulatory principles.
• Support analytical method development/validation and QC testing for cleaning validation activities.
• Review, trend, and investigate cleaning validation data; lead CAPA and deviations investigations.
• Maintain validated state through lifecycle management and implement changes with cross-functional teams.
• Provide technical training and inspection support to ensure an inspection-ready program.

Skills

Quality control

GMP compliance

Analytical thinking

Education

B.S. in Chemistry/Microbiology

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 UrgencyOutcome Focus

Skills And Capabilities

Organizational 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.

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.