IT Labs CSV Engineer - Next Generation Biotech Manufacturing
On behalf of our client who is an cutting-edge biotech manufacturing facility based in Raheen, Limerick, constructing a state-of-the-art manufacturing site with advanced technologies and innovative data collection platforms. Our mission is to deliver breakthrough improvements in safety, quality, and productivity.
The Role: Join our dynamic team as an IT Labs CSV Engineer and play a critical role in shaping the future of biotech manufacturing technology. This is an opportunity to work at the forefront of technological innovation in a greenfield manufacturing environment.
Location: Raheen, Limerick (Full-time on-site)
Key Responsibilities:
- Ensure computerized instrument systems comply with regulatory requirements
- Develop deep technical knowledge of laboratory IT equipment
- Provide technical oversight for computer system validation (CSV) processes
- Manage computer system validation projects and deliverables
- Liaise with vendors to design and integrate instrument solutions
- Lead instrument upgrades and improvement projects
- Resolve system problems using advanced data analysis
- Support audit activities and represent the site at corporate forums
Essential Requirements:
- Bachelor's Degree (Level 8) in IT, Computer Science, Engineering
- 5+ years experience in biotech/pharmaceutical environments
- Extensive computer system validation experience
- Proven administration of computerized lab equipment
- Strong troubleshooting and software understanding skills
- Deep knowledge of regulatory requirements (21CFR Part 11)
- Excellent leadership and communication abilities
Preferred Skills:
- Knowledge of IT infrastructure platforms
- Project management experience
- Expertise in laboratory IT systems (Empower, Lab Vantage)
- Familiarity with Agile methodologies
We Offer:
- Cutting-edge technological environment
- Opportunity to drive innovation
- Professional development
- Collaborative team culture
- Competitive compensation package
If you're passionate about technology and want to make a significant impact in biotech manufacturing, we want to hear from you!
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