Logo of Huzzle

Home

Matches

Explore

Manage

Lab IT & CSV Professional

image

Lilly

21d ago

  • Job
    Full-time
    Senior Level
  • Engineering
    IT & Cybersecurity
  • Cork

AI generated summary

  • You must have extensive CSV experience, lab equipment administration, troubleshooting skills, knowledge of regulatory standards, strong initiative, leadership, analytical skills, and excellent communication abilities.
  • You will ensure compliance of lab systems, manage CSV processes, coordinate validation activities, liaise with vendors, resolve system issues, support audits, and contribute to team meetings.

Requirements

  • 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.

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

FAQs

What is the main purpose of the Lab IT & CSV Professional position?

The main purpose of the Lab IT & CSV Professional position is to ensure the installation, validation, and maintenance of computerized instrument systems in laboratory and manufacturing areas, ensuring compliance with cybersecurity, data integrity, lifecycle management, and quality requirements.

What are the key responsibilities of the Lab IT & CSV Professional?

Key responsibilities include ensuring compliance with regulatory requirements, developing knowledge of lab equipment IT functionality, providing technical oversight for computerized instrument validation processes, managing validation deliverables, liaising with vendors, and supporting audit activities.

What qualifications are required for this position?

A Bachelor’s degree in Computer Science, Engineering, or a related field is required. Comparable industry experience will also be considered.

What specific skills are required for this role?

Required skills include extensive knowledge and experience in computer system validations, experience in administering computerized lab equipment, strong analytical and problem-solving skills, and effective written and verbal communication skills.

Are there any desired skills that can enhance a candidate's application?

Yes, desired skills include knowledge of IT infrastructure platforms, Industry 4.0, project management experience, familiarity with lab execution and LIMS systems, and understanding Agile methodologies.

Does this position involve working independently or as part of a team?

This position requires the ability to work both independently and as part of a cross-functional team, with strong leadership and influencing skills.

Will the Lab IT & CSV Professional support audit activities?

Yes, the Lab IT & CSV Professional will participate in and support audit activities.

Is there support for individuals with disabilities in the application process?

Yes, Lilly is dedicated to helping individuals with disabilities engage in the workforce and provides accommodations during the application process upon request.

Does Lilly promote diversity and non-discrimination in hiring?

Yes, 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.

What is the work environment for this position?

The work environment for this position is likely to be in a laboratory or manufacturing setting, where the professional will interact with a variety of computerized instrument systems.

image

Lilly

We're a medicine company turning science into healing to make life better for people around the world.

Manufacturing & Electronics
Industry
10,001+
Employees
1876
Founded Year

Mission & Purpose

Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.