Role: Laboratory IT System Engineer for Pharmaceutical Manufacturing Facility
Contract: 6+ months with possible extensions
Location: Chicago, IL
• A successful candidate will possess a minimum of a Bachelor's degree in a Computer Science, Engineering, Science or equivalent field with at least 3 years of experience within a GxP environment at a pharmaceutical / Biotechnology industry.
• Experience and knowledge of GMP, 21CFR Part 11, excellent written and verbal communication skills, and strong adherence to Good Documentation Practices.
• A successful candidate will possess:
- o Ability to identify data integrity/compliance gaps and create remediation's with minimal supervision.
- o Ability to gain technical understanding via SOPs and manuals.
- o Experience with ticketing and change management systems (Vitalize and Trackwise experience are a plus).
- o Have knowledge of laboratory software technologies with the ability to assess issues and mitigate utilizing the appropriate change control process. Benchtop equipment includes, but is not limited to: ViCell, HIAC, UV-VIS, SoftMax plate readers, cIEF, etc.
- o Experience and/or substantial understanding of Lab system principles and common system vendors' available products with the ability to engage the vendor for additional support when required.
- o Knowledge and experience administrating systems per defined SOPs: Lab Execution System (SmartLab), Empower, NuGenesis, Trackwise, Document Management System (DCA) is strongly encouraged.
- o Skills and experience working in diverse, multi-disciplined work groups, able to prioritize and allocate their time to meet the business day-to-day demands in a fast paced environment.
- o Engaged hands-on individuals that have the ability to self-direct and take initiative when an opportunity arises that requires attention and support.
• Additional skills of experience with Windows 7/10 PC configuration, HPALM, Crystal Reports, SQL Reports, and html expertise may be useful but are not required.
Stellar IT Solutions is an Equal Opportunity Employer (EOE/AA)