Systems Engineer

Lupin Ltd; New Jersey; On-site; USD 110,000 - 150,000; Full time

Job summary

Lupin Ltd in New Jersey seeks an IT Applications Systems Engineer - Manufacturing & Lab to own GMP laboratory and manufacturing IT systems and ensure compliance with FDA standards.

You will engineer solutions, perform backup/restore testing, and maintain Windows-based systems including Empower, Citrix and VMware, while partnering with QA, CSV, and manufacturing teams to keep environments robust and compliant.

Qualifications

• Bachelor’s degree in a related field.
• 5+ years operational experience in at least four IT areas relevant to laboratory and GMP manufacturing.
• Experience maintaining 21 CFR Part 11 compliant systems.
• Strong communication and cross-functional collaboration.

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.

Skills

GMP IT systems

Laboratory IT

Windows server admin

Regulatory compliance

Vendor support

Audit coordination

CSV liaison

Education

Bachelor’s Degree in related field

Tools

Empower

Citrix

VMware

Windows OS

LAC/E boxes

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

Nearest Major Market

New Jersey