Overview
Our client, a leading biopharmaceutical company based in West Dublin, is seeking a Senior Cleaning Validation Lead to support biological bulk drug substance (BDS) manufacturing operations.
In this role, the successful candidate will provide technical leadership for cleaning validation activities across upstream and downstream manufacturing processes.
The role will focus on supporting technology transfer, validation activities, and routine manufacturing operations while working closely with cross-functional teams.
The successful candidate will ensure strong cleaning validation strategies, support new product introductions, and maintain compliance with regulatory and quality standards.
Responsibilities
Provide subject matter expertise in cleaning validation for upstream and downstream biopharmaceutical manufacturing equipment.
Support cleaning validation activities for a range of process equipment, including bioreactors, media vessels, centrifuges, chromatography systems, filtration skids, buffer vessels, ultrafiltration systems, viral filtration units, and associated process equipment.
Author and review cleaning validation documentation, including strategies, protocols, reports, technical assessments, and gap analyses.
Support and defend cleaning validation strategies and studies during regulatory inspections and audits.
Provide technical leadership and guidance to a team of specialists to ensure delivery of key validation and project milestones.
Identify requirements for laboratory studies supporting cleaning validation decisions and coordinate with third-party laboratories and internal technical teams on study design and execution.
Collaborate with Quality, Supply Chain, and Manufacturing Operations teams to ensure materials and processes are available to support technology transfer and routine manufacturing timelines.
Generate technical documentation and lead the execution of plant-based studies and validation activities at commercial manufacturing scale.
Provide on-floor technical support to manufacturing teams during validation campaigns and support troubleshooting of cleaning-related issues.
Lead investigations into cleaning-related deviations and implement appropriate corrective and preventive actions.
Maintain compliance with site safety standards, cGMP requirements, and regulatory expectations.
Participate in audits, risk assessments, and incident investigations to support continuous compliance and operational excellence.
Author and review technical documentation related to cleaning activities including SOPs, material specifications, master data, APQR documentation, and regulatory submission content where required.
Provide SME support on cleaning validation activities during regulatory inspections.
Qualifications & Experience
Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
Advanced degree (MSc or PhD) in a scientific or engineering field is desirable.
Experience supporting CMC regulatory submissions or authoring technical sections for regulatory documentation.
Previous leadership experience managing cleaning validation programmes or teams.
Minimum of 10 years' experience in pharmaceutical or biopharmaceutical manufacturing environments.
Strong experience supporting bulk drug substance (BDS) manufacturing, including upstream cell culture and/or downstream purification operations.
Proven expertise in cleaning validation within commercial manufacturing environments.
Experience in cleaning cycle development, optimisation, or technical improvement initiatives is advantageous.
Strong understanding of cGMP requirements for commercial biopharmaceutical manufacturing.
Strong technical writing capability with experience authoring validation documentation and technical reports.
Experience leading or mentoring cleaning validation teams is advantageous.
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