QC Cleaning Validation Specialist - Onsite in Tralee

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

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