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Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.
PE 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.
Responsibilities
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
Defend cleaning validation strategies and studies during regulatory inspections
Provide SME leadership to a team of specialists to ensure delivery of project milestones
To 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 studies
To 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 timelines
To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
May be required to work periodically out of normal business hours during periods of validation batch execution and provide on-call support to manufacturing if required
To provide on the floor support for troubleshooting cleaning related issues and to lead manufacturing investigations into cleaning related deviations and resolution
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
To 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 submissions
To serve as a subject-matter expert (SME) on cleaning of Upstream and Downstream equipment and cleaning related support during regulatory agency inspections
Education and Experience
Minimum 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. xcfaprz
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 submissions
Previous leadership experience of Cleaning Validation activities
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to
***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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Sprachkenntnisse
- English
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