Cleaning Validation SME - Biologics Tech Services

AstraZeneca; Dublin; On-site; EUR 95,000 - 125,000; Full time

Job summary

AstraZeneca in Dublin is seeking a Cleaning Validation SME to safeguard manufacturing by building and executing robust, risk-based cleaning strategies across upstream and downstream operations. You will partner with Operations, Engineering, Quality and Regulatory to enable right-first-time batches and smooth technology transfers.

The role requires 3+ years in Technical Services or Biologics manufacturing, strong CGMP knowledge, and proven leadership of cleaning validation activities.

Qualifications

• 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 knowledge of cGMP requirements, quality systems, and global regulatory expectations for biopharmaceutical manufacturing.
• Previous experience leading Cleaning Validation activities.

Responsibilities

• Cleaning Strategy and SME Leadership: Provide expert guidance for upstream and downstream equipment cleaning.
• Validation Master Plan Ownership: Maintain and update the cleaning validation master plan and related documentation to support a multi-product drug substance facility.
• 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.

Skills

Cleaning validation

Technical writing

Cross-functional collaboration

cGMP knowledge

Attention to detail

Project management

Education

Bachelor's degree in Chemistry, Biology, Engineering

Job description

AstraZeneca in Dublin is seeking a Cleaning Validation SME to safeguard manufacturing by building and executing robust, risk-based cleaning strategies across upstream and downstream operations. You will partner with Operations, Engineering, Quality and Regulatory to enable right-first-time batches and smooth technology transfers.

The role requires 3+ years in Technical Services or Biologics manufacturing, strong CGMP knowledge, and proven leadership of cleaning validation activities.