Overview 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. Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! What You\'ll Be Doing As a Cloud Security Engineer at Lilly on the Security Architecture and Engineering team, you will play a pivotal role in a dynamic environment. Your responsibilities include managing cloud security tools (CNAPP/CSPM), conducting security reviews of cloud accounts and projects, generating proactive guidance, reviewing and creating IaC/policy as code templates, and participating in cloud design discussions. You will also contribute to the development and implementation of cloud security controls, create integrations and automations for cloud security detection and response actions, and collaborate with various stakeholders across the organization. How You\'ll Succeed Technical expertise: As a Cloud Security Engineer, you will leverage your deep technical knowledge of cloud ecosystems (AWS or Azure) to implement tailored security solutions and effectively mitigate threats and risks. Problem-solving skills: Adept problem-solving abilities are crucial in quickly identifying and addressing security issues, ensuring the development and delivery of robust cloud security solutions in a timely manner. Collaboration and communication skills: You will actively collaborate with both local and remote team members, playing a pivotal role in defining, designing, and executing cloud security strategies. Excellent communication skills are essential for this role, as you will need to engage with both technical and non-technical audiences. Agility: The ability to quickly adapt to the changing threat landscape and move at the pace of the adversary is critical to success in this role. Knowledge of cloud security trends: This role requires staying abreast of the latest developments in cloud security and integrating these insights into our practices. Balancing security and operational needs: You will balance stringent security guidelines with operational requirements, maintaining the desired corporate security posture while demonstrating empathy and understanding towards the engineering teams\' challenges and needs. Key Responsibilities Manage cloud security tools (CNAPP/CSPM) and implement cloud security controls in a multi-cloud environment (AWS and Azure). Conduct security reviews of cloud accounts and projects, generate proactive guidance, and participate in cloud design discussions. Review IaC/policy as code template proposals and provide recommendations for secure cloud deployments. Develop integrations and automations for cloud security detection and response actions to support the Cyber Defense Operations. Partner with cloud foundation teams, Cyber Defense Operations, Tech@Lilly, business areas, and suppliers to ensure secure cloud adoption and operations. Perform threat analysis and modeling to enable business and technical partners to deliver secure solutions integrated with the SecOps lifecycle. Apply threat modeling and analysis frameworks such as MITRE ATT&CK and STRIDE (or STRIDE-LM) in security practices. Maintain and expand technical knowledge across cloud security concepts and technologies, driving knowledge growth across security domains. Identify technical solutions and drive implementation to support strategic direction, focusing on value, impact, risk mitigation, security controls, privacy controls, detection, response, and quality. Prioritize mitigations in relation to technology upgrades, enhancements, and process improvements within the respective domains of accountability. Your Basic Qualifications Bachelor\'s degree in Cyber Security, Computer Science, Information Technology, or related field Or High School Diploma/GED with 4+ years of experience in Cyber Security, Information Technology, or related field. 5+ years of demonstrated experience in cloud architecture and engineering, with a focus on AWS, Azure, or GCP (slight preference for Azure). Additional Skills Strong understanding of cloud security concepts, services, and logs, including Identity and Access Management, Networking, and Security in a public cloud environment. Experience with cloud security services such as Security Hub, GuardDuty, CloudTrail, Config, VPC Flow Logs, Amazon Inspector, Amazon Detective, Cloud Custodian, Azure Policy, Azure Activity log, Defender for Cloud, Azure Sentinel, or Security Copilot. At least basic proficiency in a programming language (e.g., Python) and some experience with cloud automation and integration using tools such as Lambda, Step Functions, Glue, Azure Functions, Terraform, or CloudFormation. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLillyUKandIreland #J-18808-Ljbffr
A leading global healthcare company is seeking an Associate Director for their Quality Control Laboratories in Limerick, Ireland. This role involves leadership and governance of the QCL facility, ensuring scientific excellence, compliance, and operational efficiency. The ideal candidate will have significant management experience and a strong educational background in relevant fields. Join a team dedicated to improving lives with innovative medicines and contribute to a cutting-edge biotech facility launch. #J-18808-Ljbffr
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 has just completed construction on a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland and we are preparing to expand these facilities. These facilities will be Lilly’s most technically advanced manufacturing site and include next generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. Main Purpose And Objectives Of Position We are seeking talented and experienced bioprocess engineering professionals for multiple roles to support the expansion of the manufacturing facilities at the Limerick site. The role will provide engineering subject matter expertise to support the design, construction and preparation for the successful startup of the expanded manufacturing facilities. The successful candidate(s) will leverage existing engineering design and ongoing start up facility learnings to ensure an enhanced expanded facility start up. The available positions range from Bioprocess Engineer to Principal Bioprocess Engineer. The role and responsibility level will be commensurate with candidate experience and qualification. Key Duties And Responsibilities Facility Start-Up Phase: Provide Process Engineering support to the Global Facility Delivery team (Lilly’s Global Large Scale Capital Delivery Team) with a strong focus on right first time and on schedule facility start-up (e.g. design reviews, process safety assessments, User Requirements, C&Q support, Unit Operation Shakedown, Facility Run Rate Readiness) Define and own relevant aspects of the overall integrated Operational Readiness Plan (e.g. SOP development, maintenance strategy, automation optimization, run rate readiness, MES EBR requirements, alarm requirements, Performance Qualification Study Requirements / Protocol Development etc.). Review and support Performance Qualification strategy and execution for area of responsibility. Support initial Operations Training requirements as the Equipment and Area Subject Matter Expert (SME). Lead/support the tech transfer of new processes into the facility. Work with design and project engineers for the design review and verification activities. Support the alignment and lessons learned review between the first facility start up in Limerick and the expanded facility from design to operation start up including automation unit operations testing. Post Expansion Facility Start-Up Phase Provide process engineering support through application of process engineering fundamentals. Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team. Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions. Monitor, assess and document equipment performance to maintain ongoing qualification. Develop and maintain the basis of safety for process equipment. Develop and implement unit operation and equipment control strategy. Basic Requirements Bachelor’s, Master’s, or Ph.D. degree in Process / Chemical Engineering, Bioprocess / Biochemical Engineering, or a related field. Proven experience in bioprocess engineering, with expertise in upstream and downstream processing. Additional Preferences Deep technical interest and understanding in Large Molecule Manufacturing and Bioprocess Engineering. Strong analytical and problem-solving skills. Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science, quality and engineering professionals. Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented. Collaborative skills with operations, automation and other process engineers. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLillyUKandIreland #J-18808-Ljbffr
A global healthcare leader is seeking a Senior/Principal Engineer in Limerick, Ireland to support the design and operation of their new Biologics Manufacturing facility. The role involves developing Single Use Technology strategies, collaborating with various teams, and managing procurement for the facility. Candidates should have a Third Level Engineering Qualification and a minimum of 2 years experience in the pharma or biopharma sector. This position offers a unique opportunity to be part of a state-of-the-art manufacturing site. #J-18808-Ljbffr
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.Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions, ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together, they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!**This is a 15 Month Fixed Term Contract.**# **Organisation Overview:**Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.The GSC Regulatory Associate Director role is responsible for managing a book of work, and leading the development of a clinical submission strategy and regulatory content that ultimately enables timely approval of a Lilly medicine. The GSC Regulatory Associate Director does this by effectively collaborating across functions, geographies, and phases to deliver a feasible strategy and tactical plan to enable on time, effective study and submission packages.The GSC Regulatory Associate Director drives and influences content decisions, develops content, and leads writing teams to ensure timely and high quality delivery of key regulatory documents (e.g., regulatory interactions, submission documents and clinical study reports) that support the approval process.The GSC Regulatory Associate Director is responsible for daily operations within their area of responsibilities. This role works closely with other leadership roles to provide strategic input and ensure alignment with Lilly and Business Unit objectives.# **Primary Responsibilities:**This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.## **1. Regulatory Communication, Planning, and Strategy Development*** Partners with cross-functional, multidisciplinary teams to lead and influence planning, strategies and content for clinical development, submissions and regulatory responses.* Provides leadership and substantive advice on regulatory and submission strategy, regulations and industry best practices, demonstrating excellence in communications.* Leads regulatory writing activities and function as an integral member of clinical, project, and/or submission teams for assigned compound(s) or therapeutic area(s) and driving optimized and streamlined documents.* Consults with team leadership to plan various regulatory strategies/scenarios and their impact to make effective decisions and mitigations.* Leads and influences the development of key communications and overall regulatory communication strategies for assigned compound(s) or therapeutic area(s), providing our audience with a consistent and improved experience with our communications.* May serve as primary author on critical regulatory deliverables.* Management reviewer on critical regulatory deliverables.## **2. Portfolio Management / Delivery, as applicable*** Responsible and accountable for management/delivery of overall book of work for assigned area* Develops and executes sourcing plans to ensure seamless delivery of asset plan and priorities* Collaborates with functional management/capabilities leadership to ensure alignment of business planning and operations, coordinating across and developing synergies with therapeutic areas, phases of development, and geographies* Adjusts work plan based on shifting priorities using effective change control* Leads and directs internal and external team members in achieving team goals* Identifies and resolves issues impacting delivery of work* Partners with other GSC leads to ensure consistent communication and appropriate sourcing strategies are in place in support of overall delivery of portfolio.* Regularly reports results of team activities/metrics to leadership and stakeholders## **3. Asset- Level Subject Matter Expert/Organizational effectiveness*** Leads development of new and emerging capabilities to support the effectiveness of the GSC organization transformation,* Functions as expert on regulatory document/submission strategy, planning and execution and related industry standards and guidelines* Provides regulatory document/submission expertise to others* Analyzes and interprets new and updated industry guidelines for applicability.* In partnership with others, designs and creates training on submission/regulatory document practices for audiences within and outside of GSC.* Serves as a subject matter expert and represents GSC on committees and task forces.* In partnership with others, develops, implements, and updates Lilly policies, practices and tools and procedures that are compliant with industry guidelines.* Maintains key external industry, technical, and key professional organization connections and understandings to ensure GSC stays at the forefront of leading industry best practices# **Minimum Qualification Requirements:*** Bachelor’s degree in scientific, health, communications, or technology related field* 1 year experience in pharmaceutical medical writing focused on regulatory / submission documents* Experience leading at least 1 regulatory submission or delivering key submission activities (Safety, Efficacy Lead)* 1 year experience leading/coaching others.* 1 year experience in leading/managing a key part of portfolio or business process* Successful completion of writing exercise# **Other Information/Additional Preferences:*** Advanced degree (e.g., PharmD, PhD, MBA)* Experience in clinical development* Strong leadership, problem-solving skills, negotiation/influence/motivation, project management and critical thinking skills with ability to use effectively in a team, cross-functional setting and/or global environment.* Clinical pharmacology, therapeutic area or other medical/scientific-specific knowledge and experience (e.g., neuroscience, #J-18808-Ljbffr
A global healthcare leader in County Cork is seeking an Associate - Clinical Trial Start Up (Danish/Spanish speaking) to manage clinical trial capabilities. Responsibilities include initiating investigator site activities, ensuring compliance with regulations, and maintaining active communication with sites. Candidates must hold a Bachelor's degree in a related field and demonstrate effective project management and communication skills. Fluency in Danish or Spanish is required. Attractive benefits and a diverse working environment are offered. #J-18808-Ljbffr
A global healthcare leader is looking for a Senior Manager - QC Support in Limerick, Ireland. This role involves leading the QC Support team, ensuring compliance and operational readiness, and managing digital systems. The ideal candidate will possess a BSc, MSc, or PhD in a relevant field with substantial leadership experience in the pharmaceutical industry. Successful applicants will demonstrate strong problem-solving skills and an ability to work under pressure, ensuring that quality standards and team objectives are met. #J-18808-Ljbffr
A global healthcare leader based in Cork is seeking a Cloud Security Engineer who will manage cloud security tools, conduct security reviews, and drive the development of security controls. The successful candidate will have extensive experience in cloud architecture, especially with AWS and Azure. This role offers a dynamic working environment, including hybrid working options and competitive benefits. Join us to play a critical role in ensuring secure cloud practices and advancing your career. #J-18808-Ljbffr
Sr. Associate / Manager - Clinical Laboratory Sciences Imaging page is loaded## Sr. Associate / Manager - Clinical Laboratory Sciences Imaginglocations: Ireland, Corktime type: Full timeposted on: Posted Todayjob requisition id: R-102791At 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.Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!The TA (Therapeutic Area) Associate, Clinical Laboratory Sciences will have early engagement with the appropriate study team, business and therapeutic partners on development of the clinical laboratory, diagnostic and biomarker strategies at the trial level. The TA associate coordinates vendor activities for assigned trials as well as facilitates research and resolution to any clinical laboratory and diagnostic issues or needs throughout the life of the trial. They partner with the clinical team to provide input into the protocol development/design, develop and implement the integrated trial clinical laboratory plans and the review and monitoring of resultant data, ultimately providing high quality, combinable data in a cost effective and timely fashion.The Lilly CLS organization is unique within the pharmaceutical industry in that it is a standalone function that specializes in managing and overseeing all lab and diagnostic deliverables for Lilly’s entire clinical portfolio. In an effort to bring additional capacity and flexibility to deliver on this rapidly expanding portfolio of medicines, CLS is excited to announce that we are expanding our team into Cork, Ireland. By centralizing many aspects of CLS’ lab and diagnostic support activities in Cork, we will now be able to offer expanded hours of coverage across Europe and Asia to better support our internal clinical development partners who manage studies from outside of North America. **Responsibilities**:**1. Imaging TPO Strategy and Oversight*** Collaborate with business partners and TPOs to develop and maintain appropriate capabilities to match business needs, including the appropriate partnership to ensure data and imaging delivery.* Develop innovative clinical trial approaches related to quality, financial and operational efficiency.**2. Internal and External Engagement*** Collaborate with internal business partners regarding imaging best practices including regulations, quality and business operations.* Study level project management – including start-up, maintenance, data lock and closeout.* Establish vendor contracts – including competitive bids, budget review, and vendor selection.* Review and approve vendor documents – including manuals, training, charters, data transfer specifications.* Partner with Global Business Services centers on device and data tracking or other study maintenance and closeout tasks.* Partner with Lilly study teams as well as external vendors to ensure progress towards timelines and deliverables.**3. People Development*** Participate fully in the performance management process* Model the Lilly core values and behaviours* Provide peer coaching within the organization that fosters inclusion and innovation, continual improvement, and an external awareness and understanding**Basic Requirements:*** Bachelor’s degree in a science or related life sciences field* Prior experience in pharma, diagnostics or CRO environment**Additional Skills/Preferences:*** Demonstrated knowledge of the technical area covered by this position (eg. ECG, Imaging, genomics, safety labs, etc).* Experience in clinical research or a closely related field.* Solid knowledge of global internal, external, and regulatory requirements/expectations for connected devices or imaging.* Demonstrated skill and experience in managing alliances with outside partners (for example CROs, Patient Recruitment Management, Alliance Partners), including strong negotiation skills.* Demonstrated ability to communicate and influence across functional areas and regional geographies and culture.* Demonstrated problem solving ability and attention to detail.Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLillyUKandIrelandAt Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr
A global healthcare leader is seeking experienced bioprocess engineers for various roles to support the expansion of its advanced manufacturing site in Limerick, Ireland. The positions will involve providing engineering support throughout the construction and startup phases, ensuring operational readiness, and implementing continuous improvements. Candidates should possess a strong technical background in bioprocess engineering, with proven experience in both upstream and downstream processes. This role offers the opportunity to contribute to innovative biomanufacturing technologies. #J-18808-Ljbffr
