Description:
Exciting new position in Limerick. Extensive contract duration with an excellent daily rate on offer aligned to your experience. DON'T miss this opportunity.
Responsibilities:
- Ensure computerized instrument systems comply with regulatory requirements (21 CFR Part 11, EU GMP Annex 11, Data Integrity Guidance), company policies, and drive improvements as per regulatory changes.
- Develop expertise in the IT functionality of lab equipment to support installation, upgrades, and maintenance.
- Provide technical oversight for computerised instrument validation (CSV) processes, covering Validation Plans, Risk Assessments, Requirement Specifications, Testing, Data Migration, SOPs, Change Controls, and Deviation Investigations.
- Manage and execute computer system validation (CSV) deliverables for new and existing projects, including project planning, prioritization, and alignment with project schedules.
- Collaborate with vendors to design and deploy computerized instrument solutions integrated with onsite IT services (backup, database, patching).
- Ensure timely delivery of new instrument installations and software upgrades to meet business needs.
- Lead upgrade and improvement projects for computerized instruments, offering solutions to address business challenges.
- Troubleshoot and resolve system issues using data analysis and problem-solving skills.
- Support and participate in audit activities.
- Represent the site and share knowledge in corporate forums, fostering a network of corporate contacts and resources.
- Participate in team meetings and contribute to discussions and reporting.
Basic Requirements:
- Bachelor’s Degree (Level 8) in Information Technology, Computer Science, Engineering, or a related field.
- 5+ years of experience in a biotech or pharmaceutical setting.
- Extensive knowledge and experience in Computer System Validation (CSV), particularly for laboratory systems.
- Experience administering computerized lab equipment.
- Proven troubleshooting skills with a strong understanding of lab equipment software.
- In-depth knowledge of regulatory requirements related to CSV, including 21 CFR Part 11, security, and data integrity.
- Ability to build relationships, learn new business processes, and identify improvement opportunities.
- Strong leadership, influencing, and cross-functional teamwork skills, with the ability to work independently.
- Excellent analytical, problem-solving, written, and verbal communication skills.