DescriptionPE Global is currently recruiting for a Senior Cleaning Validation Lead on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12 month contract role.The Senior Cleaning Validation Lead has primary responsibility in supporting the cleaning validation activities for the biological bulk drug substance (BDS) manufacturing process at the facility in Dublin.The SME will provide cleaning validation expertise and leadership to a team of specialists supporting technology transfer, cleaning validation, and routine monitoring of commercial manufacturing for Upstream and Downstream manufacturing.The candidate will be responsible for leading Cleaning Validation of new and existing drug substance (DS) manufacturing processes into the Dublin facility.The candidate will be required to work in close collaboration with Process Development, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful transfer and process qualification.The position is accountable for timely completion of cleaning validation program related milestones, with particular emphasis on New Product Introduction, Cleaning Monitoring, Risk Assessment (using QRM tools), and building SME capability.ResponsibilitiesTo provide cleaning expertise in Upstream and Downstream equipment: including parts washers, media vessels, bioreactors, centrifuge, depth filtration/clarification skids, buffer vessels, purification equipment including chromatography, ultrafiltration, viral filtration skids, downstream vessels and supporting process equipmentTo author and review cleaning related documentation, gap assessments, technical protocols and reports, and cleaning validation documentation, strategy documentsDefend cleaning validation strategies and studies during regulatory inspectionsProvide SME leadership to a team of specialists to ensure delivery of project milestonesTo identify requirements for laboratory studies to support cleaning decisions, and to liaise closely with 3rd party Laboratories/Process Development / Procurement / MSAT to oversee the design and execution of cleaning studiesTo work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelinesTo generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scaleMay be required to work periodically out of normal business hours during periods of validation batch execution and provide on-call support to manufacturing if requiredTo provide on the floor support for troubleshooting cleaning related issues and to lead manufacturing investigations into cleaning related deviations and resolutionAdherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during auditsEnsure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigationsTo author and review technical documents relating to cleaning activities for SOPs, master data, material specifications, APQRs, and or common technical document (CTD) sections and reports for regulatory agency submissionsTo serve as a subject-matter expert (SME) on cleaning of Upstream and Downstream equipment and cleaning related support during regulatory agency inspectionsEducation and ExperienceMinimum of 10 years’ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in Cleaning Validation of cell culture unit operations and/or downstream unit operations. Previous experience of cleaning cycle development or cleaning cycle improvement in a technical role is advantageous.Proven expertise in leadership including demonstrated ability to drive for results and lead innovation and change.Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.Experience of leading Cleaning Validation teams is advantageous.Technical writing competency.Minimum undergraduate degree in chemistry, biology, engineering or related discipline.An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.Experience of authoring CMC sections of regulatory submissionsPrevious leadership experience of Cleaning Validation activitiesInterested candidates should submit an updated CV.Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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