Manufacturing Compliance Specialist - Site Based, Redmond, WA

About Us:

Evotec is a forward-thinking organization dedicated to innovation and excellence. We celebrate curiosity and encourage its exploration to drive success and growth.

About the role

The Manufacturing Compliance Specialist plays a crucial role in ensuring product quality and regulatory compliance. Key responsibilities include:

• Leading deviation investigations and root cause analyses
• Demonstrating strong technical problem-solving and technical writing skills
• Driving continuous process improvements
• Analyzing and trending deviations, CAPAs, and compliance metrics
• Supporting internal audits, client audits, and regulatory inspections
• Communicating information effectively through updates, reports, and summaries
• Providing routine updates on campaign, project, and investigation status
• Making critical decisions in collaboration with key stakeholders
• Exercising sound judgment and making data-driven decisions

Requirements

To succeed in this role, you should have:

• A Bachelor's or Master's degree in a science or engineering-related field (Biology, Chemistry, Biotechnology, etc.) with a minimum of 4-6 years of experience, or an Associate's degree and 10+ years of experience in a GMP manufacturing environment
• Previous hands-on experience in a regulated (e.g., GMP, Aerospace) operations environment
• Experience in investigating and resolving production non-conformances, implementing CAPA/Change Controls, and leading improvement projects
• Strong proficiency in Microsoft Office tools (Word, Excel, PowerPoint)
• Familiarity with electronic quality management systems (e.g., Veeva, TrackWise, MasterControl)
• Strong knowledge of cGMP regulations, FDA regulations, ICH guidelines, data integrity principles, and quality risk management practices
• Strong leadership, organizational, communication, technical, and writing skills

Qualifications

Preferred qualifications include:

• Experience supporting commercial biologics, cell therapy, gene therapy, or vaccine manufacturing
• Experience in operations enterprise systems such as DeltaV, MES, and SAP
• Experience supporting regulatory inspections and audits
• Knowledge of validation lifecycle activities

Benefits

Additional total rewards include:

• Discretionary annual bonus
• Comprehensive benefits package (Medical, Dental, Vision, Short-term and Long-term disability, company-paid basic life insurance, 401(k) company match, flexible work, generous paid time off, paid holidays, wellness, and transportation benefits)

Pay

The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; Base salary offered may vary depending on the individual's skills, experience, and competitive market value.

Schedule

This role is site-based.

Equal Opportunity Employer

Evotec 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.