Industry Pharma/Biotech/Clinical ResearchWork Experience 5+ yearsCity CarlowState/Province CarlowCountry IrelandJob DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.Overview:Our site is excited to offer a fantastic SeniorEngineering Specialist (Validation) opportunity for candidates interested in anew challenge in a cGMP regulatory environment. The successful candidate willsupport Cleaning Validation including Recovery/Cleanability studies.RequirementsResponsibilities:Design/Author/Review/Approve/Executequalification/validation documentation and cycle development studies in linewith the standard approval process.Design/Author/Review/Approve/ExecuteExecution/development of change controls.Resolving technical issues encountered during studyexecution.Engagement with Production, Maintenance and Qualityrepresentatives in the assigned area of operations during execution of CycleDevelopment & Performance Qualification activities.Technical input into quality notification byauthoring/reviewing/approving investigations.Perform root cause analysis of system failures,substandard performance, using standard tools and methods, to resolve machineand system issues.Support continuous improvement through Lean Six Sigmamethodologies.Serve as validation representative for cross functionalprojects and represent the validation team at global technical forumsDrive compliance of Global Policies, Procedures andGuidelines, regulatory requirements and execute current Good manufacturingPractices (cGMP) in the performance of day-to-day activities and all applicablejob functions, ensuring consideration of the impact on GMP and compliance anddecisions made.Accountable for compliance via documentation completion,risk assessments, closing out corrective actions, participation in audits andinspections and proactively highlighting any issues around complianceSupporting regulatory audits and submissions as required.Work collaboratively to drive a safe and compliantculture .May be required to perform other duties as assigned.Experience, Knowledge & Skills:Experience in cleaning validation including but notlimited to CD & PQ of mobile vessels (CIP) and parts washers (COP)including recipe development & optimisation, cleaning verification,cleanability and recovery studies using TOC, ICP & swab methods, acceptableresidual limit determination, worst case soil matrices & strategydevelopment.Considerable experience in a comparable role, withexperience operating as individual contributor adding value to the business ina GMP manufacturing setting, as well as the following qualifications/skills:Relevant technical qualification(s) in AppliedPharmaceutical / Biological / Chemical sciences or applied Technical /Engineering qualification, the successful candidate will also have a proventrack record in delivering excellence.Exception / Deviation Management and Change Control.Demonstratable experience of leading technical relatedprojects.Knowledge of process monitoring systems, automationsystems (DeltaV), operational intelligence & data systems (Pi System)within a GMP manufacturing environment would be beneficial and desirableEvidence of continuous professional development isdesirable.Knowledge of regulatory/code requirements to Irish,European and International Codes, Standards and Practices.Ability to analyse and interpret complex data, and linkto equipment performance and out of specification findings as appropriate.Equipment and process validation.Sterile Fill-Finish processes and equipment.Proficiency in Microsoft Office and job-related computerapplicationsExcellent communication, presentation, and interpersonalskills, to interface effectively with all levels of colleagues and withexternal customers in a team orientated manner.Knowledge and experience of the below areas will beconsidered advantageous:Filter ValidationShipping QualificationEquipment Periodic ValidationEquipment Validation LifecycleProject Management Skills/QualificationIsolator VHP/HVAC QualificationControlled Temperature Units/Equipment QualificationVial and Syringe Processing TechnologiesQualifications & Education:Relevant technical qualification(s) in AppliedPharmaceutical / Biological / Chemical sciences or applied Technical /Engineering qualification
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