QC Cleaning Validation Specialist (IE)
Notify me about similar jobsAbout this opportunity
.
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
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.
#LI-Onsite
#LI-Tralee
#LI-JU1
]]>
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1523 comparable Quality roles across 149 biopharma companies.
Salary context
248 of 1523 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1523 comparable roles
+ 47 more countries
Seniority mix
690 of 1523 peers have a known seniority level
Therapeutic area mix
1 of 1523 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Quality job in Ireland, and choose locations and companies.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.