Principal IT System Site Lead (GMP)

At Just-Evotec Biologics, curiosity sparks innovation and success in our forward-thinking team. The Principal GMP IT System Site Lead ensures computerized systems in regulated pharmaceutical environments comply with GxP regulations and data integrity standards. This senior role leads validation, gathers requirements, configures software, and bridges IT, quality, and business stakeholders.

Oversee maintenance, upgrades, and management of IT infrastructure including networks, servers, databases, and applications while ensuring cybersecurity. Manage site-specific IT projects on time and within budget, negotiate with vendors for cost-effective solutions, and develop IT policies for regulatory compliance. Lead hands-on configuration, troubleshooting, and support for GMP/GLP systems.

Lead Computer System Validation projects with plans, scripts, and IQ/OQ/PQ reports per 21 CFR Part 11 and GxP guidelines. Translate user requirements into specifications, create SOPs and documentation, and manage change controls with risk assessments. Mentor junior analysts and liaise between vendors and internal business units.

Thrive in a team that challenges the status quo, learns together, and celebrates curiosity with #BeCureious. Enjoy growth through continuous learning, professional courses, mentorship, and new projects. Push boundaries in a mission to innovate in biologics.