Systems Engineer

Lupin; Northern (KY); Hybrid; USD 100,000 - 130,000; Full time

Job summary

Lupin seeks an IT Applications Systems Engineer - Manufacturing & Lab in the United States (Kentucky region) to own responsibility for pharmaceutical laboratory and GMP manufacturing IT systems. You will engineer solutions to complex IT issues and ensure systems are maintained in compliance with FDA standards.

Responsibilities include managing laboratory and GMP manufacturing systems, backup/restoration testing, and supporting Empower, Citrix, and VMware environments.

Qualifications

• Bachelor’s degree in a related field.
• 5+ years operational experience in GMP IT environments.

Responsibilities

• Owns responsibility for laboratory and GMP manufacturing systems, including stand-alone and firmware-based systems.
• Backup and restore testing of all critical GMP systems.
• Builds and troubleshoots 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 IT systems and acts as liaison between IT and CSV.
• Defends GMP IT systems during audits and ensures systems are properly configured and maintained to comply with agency standards.
• Excellent written and oral communication skills.

Education

Bachelor’s degree in related field

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