Systems Engineer

Lupin•Franklin Township, NJ

29d•$70,000 - $95,000•Onsite

About The Position

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.

Requirements

Bachelor's Degree in Information Technology, Computer Science, Engineering, Life Sciences, or related field.
Minimum 5 years of experience supporting GMP-regulated pharmaceutical manufacturing and laboratory systems.
Working knowledge of FDA 21 CFR Part 11, GAMP 5, Annex 11, and Data Integrity requirements (ALCOA+ principles).
Experience supporting validated computerized systems in a regulated pharmaceutical environment.
Experience with change control, deviations, CAPA, and audit support.
Excellent written and oral communication skills

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