Cleaning Validation Lead — Biologics GMP Expert

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

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.