Principal IT Business Analyst – GxP Manufacturing Execution Systems (MES)

Job Title: Principal IT Business Analyst GxP Manufacturing Execution Systems

Location: Seattle Washington
Reports To: Senior Director Information Technology

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 whats possible. Were on a mission to create a place where curiosity isnt just encouraged its celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper#BeCureious with us and see where your curiosity can take you!

The Role:

As a Principal IT Business Analyst you will serve as a strategic partner in shaping and optimizing GxP-compliant Manufacturing Execution Systems (MES) for a rapidly growing biotech organization. This role is pivotal in enabling compliant efficient and scalable manufacturing operations that support life-saving therapies. You will lead initiatives that integrate cutting-edge technologies ensure regulatory adherence and drive operational excellence across our Seattle-based manufacturing site.

We are seeking a highly experienced and influential IT Business Analyst with deep expertise in GxP-regulated MES this Principal-level role you will provide thought leadership define system strategies and guide complex implementations to ensure alignment with compliance requirements and business objectives. You will collaborate closely with Manufacturing Quality and IT leadership to deliver robust validated solutions that support electronic batch records recipe management and seamless integration with enterprise systems. Additionally you will mentor and coach junior analysts and team members fostering a culture of knowledge sharing and continuous improvement.

What Youll Do:

• Define and influence MES strategy roadmap and governance to support long-term manufacturing goals.

• Act as the primary liaison between senior business stakeholders and IT for MES initiatives ensuring alignment with operational and compliance priorities.

• Lead the collection analysis and translation of complex business requirements into functional specifications and system configurations.

• Oversee system implementation and validation activities in accordance with GxP 21 CFR Part 11 and data integrity standards.

• Drive MES integration with ERP automation systems LIMS CMMS and other enterprise platforms to enable end-to-end digital manufacturing.

• Provide advanced troubleshooting root cause analysis and continuous improvement for MES-related processes and technologies.

• Develop and maintain high-quality SOPs validation documentation and training materials for MES systems.

• Lead upgrades enhancements and cross-functional projects using Agile or hybrid methodologies.

• Ensure uninterrupted manufacturing operations through proactive monitoring and escalation management for critical MES processes.

• Coach and mentor junior analysts and team members providing guidance on best practices compliance standards and technical problem-solving.

Who You Are:

• Bachelors degree in Information Technology Computer Science Engineering or related field (Masters preferred).

• 8 years in IT Business Analysis or similar roles within regulated (GxP) environments.

• Proven leadership in MES platforms (e.g. PAS-X Syncade Camstar Siemens Rockwell).

• Deep understanding of GxP principles Computer System Validation (CSV) and electronic records/e-signature compliance.

• Strong knowledge of integration between MES ERP automation/historian LIMS and CMMS systems.

• Exceptional analytical problem-solving and stakeholder management capabilities.

• Familiarity with quality processes: Change Control Deviations CAPAs Investigations and Root Cause Analysis.

Additional Qualifications

• Experience with electronic batch records (EBR) and recipe management.

• Knowledge of biotech/pharma manufacturing processes.

• Familiarity with Agile or hybrid project methodologies.

Cultural Fit

• Strategic thinker with the ability to influence and drive change across functions.

• Strong collaboration and communication skills for engaging senior stakeholders.

• Adaptability in a fast-paced dynamic environment.

• Commitment to compliance data integrity and continuous improvement.

• Passion for developing talent and fostering team growth.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life with hybrid work schedules in many of our various locations.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll 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 dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mind just like us. So what are you waiting for Take the leap and apply today. We cant 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 at commencement of employment is expected to be $145000 to $170000; Base salary offered may vary depending on individuals skills experience and competitive market value.

Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision short-term and long-term disability company paid basic life insurance 401k company match flexible work generous paid time off and paid holiday wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.