Technical Services – Cleaning Validation Senior SpecialistLocation: DublinReports To: Manager Cleaning Validation
This is what you will do:
The Cleaning Validation Senior Specialist has primary responsibility in supporting the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin. The Cleaning Validation Senior Specialist will provide cleaning validation expertise to support routine commercial manufacturing and technology transfer of Upstream and Downstream manufacturing of new/existing drug substance (DS) manufacturing processes to the Dublin facility. The person will be required to work in close collaboration with Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to provide successful cleaning support. The person should have experience in leading cleaning programs for Upstream and Downstream equipment, Cleaning Validation (CV), Cleaning Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability. The person should have experience in presenting and defending cleaning validation strategies during regulatory inspection.
You will be responsible for:
To 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 equipment
To author and review cleaning related documentation, gap assessments, technical protocols and reports, and cleaning validation documentation, strategy documents
Maintain/update to the cleaning validation plans and any associated cleaning related documentation to support the multi-product drug substance manufacturing facility at ADMF
To identify requirements for laboratory studies to support cleaning decisions, and to liaise closely with 3rd party Laboratories/Process Development / MSAT to oversee the design and execution of cleaning studies
To identify and implement cleaning related process improvements, e.g. cleaning cycle optimisation, cycle time reduction
To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
To provide on the floor support for troubleshooting cleaning related issues and to lead manufacturing investigations into cleaning related deviations and resolution
Lead any key cleaning related change controls using the change control system
To serve as a subject-matter expert (SME) on cleaning of Upstream and Downstream equipment and cleaning related support during regulatory agency inspections
To author and review technical documents relating to cleaning activities for SOP’s, master data, material specifications and or common technical document (CTD) sections and reports for regulatory agency submissions
Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits
Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations
May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing and participation in on-call roster
You will need to have:
Minimum 6+ years’ experience in Cleaning Validation in a biological bulk drug substance manufacturing organization
Technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems and regulatory requirements across multiple health authorities
Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization and in local group settings
Ability to present and defend technical and scientific approaches in both written and verbal form
Ability to drive for results independently and adapt to rapidly changing priorities
Experience in cleaning validation and cleaning approaches to a multiproduct facility is advantageous
Detail orientated
Technical writing competency
We would prefer for you to have:
B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
#J-18808-Ljbffr