IT Labs CSV Engineer

2 weeks ago

Dublin, Dublin City, Ireland Eli Lilly and Company Full time

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 currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly's most technically advanced manufacturing site and will 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.

Join our team of experienced IT professionals at a greenfield biotech manufacturing site and help shape the future of biotech manufacturing. We are seeking motivated individuals with a passion for cutting-edge technologies and a strong background in IT to fill the open roles.

This position is based full-time on site in Raheen, Limerick.

Responsibilities:

  • Responsible for ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures and will drive improvements in line with regulatory changes (including but not limited to 21 CFR Part 11, EU GMP Annex 11 and Data Integrity Guidance).
  • Develop in-depth knowledge of IT functionality of relevant lab equipment to aid in installation, upgrade and maintenance activities.
  • Provide technical oversight for computerised instrument validation (CSV) processes, in accordance with site and corporate procedures and GMP guidelines. The activities include, but are not limited to; the oversight for Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing, Data Migration, SOPs, Change controls and Deviation Investigations.
  • Manage, co-ordinate, develop and execute computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with the overall project schedules.
  • Liaise with vendors to design and deploy computerised instrument solutions to integrate with existing onsite IT services & infrastructure (backup, database, patching etc.).
  • Ensure new instrument installations and software upgrades are delivered in time to meet business needs.
  • Lead computerised instrument upgrades and improvement projects, promoting and providing solutions to business problems.
  • Resolve system problems using data analysis and problem-solving skills.
  • Participate in and support audit activities.
  • Represent the site and share knowledge at corporate forums.
  • Develop a 'network' of corporate contacts and resources.
  • Participate, contribute and report at team meetings.

Basic Requirements:

  • Bachelor's Degree (Level 8) in Information Technology, Computer Science, Engineering or related field.
  • Minimum of 5+ years of experience in a biotech or pharmaceutical setting.
  • Extensive knowledge and experience in development and execution of Computer system validations, in particular the laboratory systems area.
  • Experience in administration of computerised lab equipment.
  • Demonstrated troubleshooting ability, understanding of lab equipment software.
  • Extensive understanding of regulatory requirements associated with CSV, including ER/ES (21CFR Part 11), security and data integrity.
  • Demonstrated initiative to build relationships, learn new business processes and identify opportunities.
  • Strong leadership and influencing skills and the ability to work in cross-functional team environments, as well as independently.
  • Strong analytical and problem-solving skills are required.
  • Strong written and verbal communication skills are required.

Additional Skills/Preferences:

  • Knowledge of IT infrastructure platforms and ISA S95 architecture.
  • Project management experience.
  • Strong working knowledge of quality control laboratory IT systems (i.e. Empower, Lab Vantage, etc.).
  • Familiar with Agile methodologies.
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