Biologics Cleaning Validation Lead - Technical Services

AstraZeneca GmbH; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

AstraZeneca in Dublin, based in College Park, seeks a Cleaning Validation SME to safeguard biologics manufacturing by building and executing 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, drive audits readiness, and support technology transfers with rigorous documentation and on-the-floor troubleshooting.

Qualifications

• 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.

Responsibilities

• Lead cleaning strategy for upstream and downstream equipment, ensuring lifecycle management.
• Own the Validation Master Plan and related regulatory documentation.
• Author and review cleaning-related documentation, gap assessments, strategy documents, and SOPs.

Skills

Cleaning validation

Technical writing

Cross-functional collaboration

Stakeholder influence

Attention to detail

Education

Bachelor's degree in Chemistry, Biology, Engineering

Tools

TOC

HPLC

CIP/SIP

Job description

AstraZeneca in Dublin, based in College Park, seeks a Cleaning Validation SME to safeguard biologics manufacturing by building and executing 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, drive audits readiness, and support technology transfers with rigorous documentation and on-the-floor troubleshooting.