Process Sme – Api

2 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

Process SME – API - Ireland, Dublin - 12 Month ContractHow would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country?If yes, then this is the assignment for youOur client is currently seeking the skills of Process SME to join their team.Our client develops and delivers life changing medicines to millions of people globally and as part of their growth.With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involvedResponsibilitiesUnderstand business objectives, project scope, schedule, and critical success factorsUnderstand and engage project stakeholders relevant to SME roleParticipate in the APICOM capital project team through all phases of projectUnderstand your project remit in terms of scope of work and interfaces with other SME's scope of works.Ensure requirements are appropriately documented and agreed with project stakeholdersAll GMP URSs to be documented and agreed with project stakeholders in basic designWork collaboratively with project stakeholders, including collaboration between other packages and disciplinesEnsure requirements are understood and included in the scope of works of designerProactive engagement with designer to ensure design is being developed in line with requirementsProduce agreed project deliverables in accordance with project schedule deadlinesSupport work package owners in understanding requirements and design basis and in planning and delivery of work packagesSupport procurement activities, as requiredConsulted on work package breakdown and scope of worksParticipation in project meetings, design meetings, SME meetings, and project tier meetings, as agreed with PTMRaise issues and escalate through agreed project processesInput into project risk register and project/work package cost/schedule reviewsResponsible for design assurance reviews for assigned technical packagesConsulted on C&Q planInput into SHE risk assessments and Engineering Compliance trackerReporting of progress, issues, and escalations to ETS tier processReview design deliverables to validate that they meet requirements, Including Design Qualification for GMP packagesSupport PTM in preparation for Engineering CouncilPrepare requirements for Detailed DesignParticipate in project learning reviewsDesirable ExperienceExperience with API (Small molecule) & Process designStrong stakeholder management.Assess equipment needs and support the generation of equipment URS and specifications for design or purchaseExperience with GMP URSs, which will be agreed with project stakeholders in basic designEnsure requirements are understood and included in the scope of works of designerConsult in the C&Q planIf this role is of interest to you, please apply now#J-*****-Ljbffr

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    Dublin Pike, Ireland Quanta Consultancy Services Ltd Full time

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