Principal IT System Site Lead (GMP)

Job title: Principal IT System Site Lead (GMP)

Location: Redmond

Reports to: Director, IT Program Management

About Us:

At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged, it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!

The Role:

Principal GMP IT System Site Lead is a senior-level IT role ensuring that computerized systems used in regulated environments (pharmaceutical, biotech, medical device) comply with GxP Regulations and data integrity standards. They lead system validation, gather requirements, configure software, and manage system lifecycles while bridging the gap between IT, quality departments, and business stakeholders. 

What You'll Do:

• IT Infrastructure and Security: Oversee the maintenance, upgrade, and management of IT infrastructure, including networks, servers, databases, and software applications. Ensure robust cybersecurity measures are in place to protect data and IT resources.

• Project Management: Manage and deliver site specific IT projects on time and within budget. This includes planning, executing, monitoring, and closing projects.

• Vendor Management: Negotiate with and manage relationships with technology vendors and service providers to ensure cost-effective and high-quality solutions.

• Policy and Procedure Development: Develop and implement IT policies, procedures, and best practices. Ensure compliance with legal and regulatory requirements.

• System Validation & Compliance: Leads Computer System Validation (CSV) projects, including creating validation plans, scripts, and reports (IQ/OQ/PQ) to ensure compliance with 21 CFR Part 11 and GxP guidelines.

• Requirements Gathering & Analysis: Translates complex user requirements into functional and technical specifications for laboratory or manufacturing systems.

• System Configuration & Support: Performs hands-on configuration, system administration, and technical troubleshooting for GMP/GLP systems.

• Documentation & SOPs: Creates and updates standard operating procedures (SOPs), technical manuals, and data integrity documents.

• Change Control & Risk Management: Manages change control requests for validated systems, conducting risk assessments to maintain the validated state.

• Strategic Leadership: Mentors junior analysts and acts as a key liaison between software vendors and internal business units. 

Who You Are:

• Experience: 10+ years of experience in systems analysis, with strong expertise in GxP/regulated environments.

• Technical Knowledge: Proficiency with Computer System Validation (CSV) and Data Integrity requirements.

• Regulatory Knowledge: In-depth understanding of FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines.

• Skills: Excellent analytical skills, technical writing, vendor management, and project management capabilities. 

• Education: Bachelor’s degree in Computer Science, Information Technology, or a relevant scientific field (e.g., Biology, Chemistry). 

Why Join Us: 

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow. 

• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged. 

• Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. 

• A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them. 

Are You Still Curious? 

If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of Just-Evotec.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Just-Evotec! 

The base pay range for this position a