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Job Description
Description:
The IT Applications Systems Engineer - Manufacturing & Lab will own responsibility for pharmaceutical laboratory and GMP manufacturing IT systems. This role will engineer solutions to complex IT issues related to those areas, and ensure systems are continually maintained in a manner consistent with FDA standards and requirements. This individual will work across business units to ensure our laboratory and manufacturing systems environments are well supported and maintained.
Responsibilities:
- Owns responsibility for laboratory and GMP manufacturing systems, including stand alone and firmware based systems
- Responsible for backup and restore testing of all critical GMP systems
- Builds and troubleshoots Microsoft Windows based systems including LAC/E boxes
- Maintains 21 CFR Part 11 compliant laboratory and manufacturing related server systems including Empower, Citrix, VMWare
- Investigates complex system problems in partnership with system vendors, and provides necessary support
- Works across internal business units to maintain and manage IT systems, and acts as primary liaison between IT and CSV
- Defends GMP IT systems during an audit, and ensures all systems are properly configured and maintained on an ongoing basis to comply with all relevant agency standards and requirements
- Excellent written and oral communication skills
Qualification and Experience
Bachelor's Degree in related field
- 5+ years operational experience in at least four of the following areas
Competencies
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility