Biologics Cleaning Validation Lead

Alexion Pharma Spain S.L.; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

AstraZeneca is seeking a Cleaning Validation SME based in Dublin to lead cleaning strategies across upstream and downstream biopharma operations, partnering with Operations, Engineering, Quality, QC and Regulatory to enable right-first-time batches and smooth technology transfers.

You will own the Validation Master Plan, author documentation, design plant-scale studies, support tech transfers, resolve issues during validation, and ensure cGMP compliance and audit readiness in a fast-paced

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or related field.
• 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.

Responsibilities

• Develop and execute cleaning strategies for upstream and downstream equipment.
• Own the cleaning validation master plan and related docs.
• Author and review cleaning-related documentation, SOPs, APQRs, and technical sections.
• Design and lead plant-scale validation studies with cross-functional teams.
• Support technology transfer with defined cleaning strategies and acceptance limits.
• Provide on-the-floor support during validation batches and lead CAPA investigations.
• Ensure compliance with EHS, cGMP and regulatory expectations; support inspections.
• Influence stakeholders to align on risk-based cleaning decisions.

Skills

Cleaning validation

Technical writing

Cross-functional collaboration

Attention to detail

Problem solving

Education

Bachelor's degree in Chemistry / Biology / Engineering

Tools

TOC

Conductivity

HPLC

CIP/SIP

Job description

AstraZeneca is seeking a Cleaning Validation SME based in Dublin to lead cleaning strategies across upstream and downstream biopharma operations, partnering with Operations, Engineering, Quality, QC and Regulatory to enable right-first-time batches and smooth technology transfers.

You will own the Validation Master Plan, author documentation, design plant-scale studies, support tech transfers, resolve issues during validation, and ensure cGMP compliance and audit readiness in a fast-paced