Eli Lilly and CompanySenior/Principal Bioprocess Engineer - Single Use (Consumables)
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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 Technology drawings 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 for Single Use Technology items.
Identify the Single Use Technology requirements to support commissioning/qualification and verification activities, and procure to support project schedule.
Procurement Support
Identify appropriate Single Use Technology suppliers, 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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