Cleaning Validation Specialist, Technical Services

Alexion Pharmaceuticals, Inc.; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

AstraZeneca in Dublin (College Park) seeks a Cleaning Validation SME to safeguard biologics manufacturing by defining robust, risk-based cleaning strategies across upstream and downstream operations.

You will partner with Operations, Engineering, Quality, Regulatory and MSAT to enable right-first-time batches, smooth technology transfers and audit-ready documentation. Strong writing, collaboration and problem-solving are essential for success in a fast-paced, multi-product facility.

Qualifications

• BS in Chemistry, Biology, Engineering, or related field.
• 3+ years in Technical Services, Process Development, or Manufacturing in biologics.
• Knowledge of cleaning validation/verification for upstream and downstream equipment.
• Solid understanding of cGMP, quality systems, and global regulatory expectations.
• Experience leading Cleaning Validation activities.

Responsibilities

• Lead cleaning strategy for upstream/downstream equipment and lifecycle.
• Maintain and update the cleaning validation master plan and related docs.
• Author and review cleaning-related documentation and SOPs.
• Design and execute plant-scale studies, coordinate with external labs.
• Support technology transfer with defined cleaning strategies.
• Provide on-the-floor support during validation batches and investigations.
• Ensure compliance and audit readiness; interface during inspections.
• Collaborate with cross-functional teams to align risk-based decisions.

Skills

Cleaning strategy

cGMP knowledge

Technical writing

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Chemistry, Biology, Engineering, or related scientific discipline

Tools

TOC

Conductivity

HPLC

Job description

Are you ready to set the standard for cleaning validation that protects patients and powers reliable biologics supply? Based in College Park, Dublin, you will safeguard the integrity of commercial-scale biologic drug substance manufacturing by building and executing robust, risk-based cleaning strategies across upstream and downstream operations.

You will join a high-performing Technical Services team as the cleaning validation subject matter expert, partnering closely with Operations, Engineering, Supply Chain, Quality, Quality Control and Regulatory to enable right-first-time batches and smooth technology transfers. Do you thrive on turning complex risk assessments into clear, confident decisions that keep plants moving and audit-ready?

Accountabilities

• Cleaning Strategy and SME Leadership: Provide expert guidance for upstream and downstream equipment, including parts washers, media and buffer vessels, bioreactors, centrifuges, clarification skids, chromatography systems, ultrafiltration, viral filtration skids, downstream vessels and supporting process equipment, ensuring effective and efficient cleaning lifecycle management.
• Validation Master Plan Ownership: Maintain and update the cleaning validation master plan and related documentation to support a multi-product drug substance facility, aligning with evolving processes and regulatory expectations.
• Documentation Excellence: Author and review cleaning-related documentation, gap assessments, strategy documents, technical protocols and reports; develop and maintain SOPs, master data, material specifications, APQRs and technical sections for regulatory submissions.
• Study Design and Execution: Generate protocols and lead the execution of plant support and technical studies at commercial scale; identify laboratory study needs and coordinate with third-party laboratories and process development/MSAT to design and deliver the right data for decisions.
• Technology Transfer Enablement: Define and implement cleaning strategies and acceptance limits that enable the introduction of new and existing processes with predictable timelines and strong compliance outcomes.
• On-the-Floor Support and Issue Resolution: Provide real-time support during validation batches, troubleshoot cleaning issues, and lead investigations into cleaning-related deviations through to effective CAPA; provide on-call support and work outside normal hours as needed during validation execution.
• Compliance and Audit Readiness: Drive adherence to EHS, cGMP and corporate standards; participate in risk assessments, audits and incident investigations; serve as a technical interface during internal and external inspections.
• Cross-Functional Influence: Align stakeholders on risk-based cleaning decisions and priorities, ensuring that technical choices translate into reliable supply, high-quality outcomes and patient impact.

Essential Skills/Experience

• Bachelor's degree in Chemistry, Biology, Engineering, or related scientific discipline.
• 3+ years' experience in Technical Services, Process Development, or Manufacturing within a biologics manufacturing environment.
• Technical knowledge of cleaning validation/verification for upstream and downstream manufacturing equipment.
• Strong understanding of cGMP requirements, quality systems, and global regulatory expectations for biopharmaceutical manufacturing.
• Previous experience leading Cleaning Validation activities.
• Strong written and verbal communication skills, with the ability to influence and collaborate across functions and organisational levels.
• Demonstrated technical writing and presentation skills, including the ability to communicate and defend scientific and technical approaches.
• Self-motivated, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
• Proven ability to navigate complexity, exercise sound judgement, and adapt to changing business needs.
• Results-oriented with the ability to work independently and deliver outcomes in a matrix organisation.

Desirable Skills/Experience

• Experience applying QRM tools to cleaning risk assessments and lifecycle management.
• Background in multi-product biologics facilities, including setting residue limits and campaign planning.
• Hands-on experience with analytical methods for cleaning verification, such as TOC, conductivity and HPLC.
• Familiarity with CIP/SIP systems, automation and data systems supporting cleaning validation.
• Track record of preparing for and supporting regulatory inspections with a focus on cleaning validation.
• Experience coordinating third-party laboratories and MSAT for design and execution of cleaning studies.
• Demonstrated success delivering cleaning readiness as part of technology transfers.

Why AstraZeneca

Here, your work carries real-world meaning—securing safe, reliable medicines for people with serious and often under-served conditions. You will feel the entrepreneurial energy of a nimble biotech environment, backed by the resources and stability of a global leader in science. Expect unexpected teams in the same room unleashing bold thinking, access to cutting-edge technology and the chance to take true ownership of your craft. We value kindness alongside ambition, encourage you to stretch beyond your lane, and support you with tailored development so you can grow your impact while growing your career.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.