Cleaning Validation Specialist, Technical Services

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