Senior/principal bioprocess engineer - single use (consumables)

Lilly allie le soin à la découverte pour améliorer la vie des gens partout dans le monde. Lilly est un chef de file mondial des soins de santé, avec son siège à Indianapolis. Nos collaborateurs travaillent à découvrir et à fournir à ceux qui en ont besoin des médicaments qui transforment la vie, à améliorer la compréhension et la gestion des maladies et à redonner à nos communautés grâce à la philanthropie et au bénévolat. Nous donnons le meilleur de nous-mêmes à notre travail, et nous accordons la priorité aux personnes. Nous recherchons des collaborateurs déterminés à améliorer la vie des gens dans le monde entier.

Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.

Responsibilities:

We are seeking a strong Senior/Principal Engineer experienced with Single Use Technology to support our new next generation Biologics Manufacturing Facility at Raheen Co. Limerick.

Some key responsibilities of the role include;

Design

* Close collaboration with Site Engineering, Operation, Quality and Technical Services teams to develop Single Use Technology site strategy.

* Develop Single Use Technology flow diagrams to describe Single Use Technology flowpaths of the entire process train, and Single Use Technology interaction with Stainless Steel systems.

* Establish Process Closure requirements based on the facility design.

* Establish standardization methodology to specify Material of Construction, sizes, connector types to simplify design, standardize across the facility, and reduce supply chain risk.

* Support facility design reviews to ensure Single Use Technology issues considered.

* Build relationship with Single Use Technology vendors, and collaborate closely to develop detailed component level Single Use Technologydrawings by providing detailed requirements/specification to facilitate expedited design agreement.

* Establish Single Use Technology database to capture all Single Use Technology designs and data.

* Manage change to Single Use Technology designs, ensuring standardization approach maintained and SKU count minimized across project lifecycle.

* Facilitate workshops and reviews with internal stakeholders (Engineering, Quality, Operations, Regulatory, Tech Services etc.) to define Single Use Technology process requirements for each process step.

* Facilitate the development and approval of Specifications forSingle Use Technology items.

* Identify the Single Use Technologyrequirements to support commissioning/qualification and verification activities, and procure to support project schedule.

Procurement Support

* Identify appropriate Single Use Technologysuppliers, support qualification of suppliers by execution of Audits, and assist with establishing supply agreements.

* Identify the quantity of each Single Use Technology items required over the phase of the project, and for ongoing Operations to facilitate Procurement activities.

* Support Procurement team with technical and commercial queries in cost assessments.

Ongoing Support

* Support Single Use Technology Change Management.

* Improve supply chain resilience by establishing dual sourcing arrangements and qualifying alternative Material of Construction for critical applications

* Support root-cause investigations, and close-out of Single Use related corrective and preventative actions.

Manufacturing & Quality Support

* Manage the process to ensure Extractable & Leachable assessments are completed in accordance with project schedule.

* Facilitate process by ensuring Extractable & Leachable data for all Material of Constructions is provided by all Single Use Technology vendors as required.

* Review & approve risk assessments, calculations and reports.

Pre-Requisites:

* Educational Requirements:Third Level Engineering Qualification or equivalent

* Minimum of 2 years relevant industry experience pharma & biopharma sector

Training

* On the job learning with experienced personnel will be provided

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