- 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
- 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.
- Knowledge of IT infrastructure platforms and ISA S95 architecture
- Knowledge of Industry 4.0
- Project management experience
- Knowledge of lab execution & LIMS systems
- Familiar with Agile methodologies
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Lab IT - Kinsale, Ireland - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
Main Purpose and Objectives of Position
The Lab IT & CSV Professional is a member of the site IT & CSV team which has responsibility for the installation, validation and maintenance of a wide variety of computerised instrument systems in both laboratory and manufacturing areas.
The Lab IT & CSV Professional will ensure that computerised instruments systems meet all cybersecurity, data integrity, life cycle management and quality requirements.
Key Responsibilities
Required Skills
Desired Skills
Educational Requirements:
BS in Computer Science, Engineering or related field. Comparable industry experience will also be considered.
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.
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