Location: Redmond, WA
Department: Manufacturing Compliance
Reports To: Director, Manufacturing Compliance

The Role: / your challenge, …in our journey

We’re looking for a passionate and curious Manufacturing Compliance Specialist to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Manufacturing Compliance Specialist at Evotec, you are responsible for leading deviation investigations, managing Corrective and Preventive Actions (CAPAs) and change controls (CHG) to maintain the highest levels of product quality and regulatory compliance. You'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

What You’ll Do:

• Lead deviation investigations and root cause analyses to identify, document, and resolve manufacturing and quality events.

• Demonstrate strong technical problem-solving capabilities and excellent technical writing skills to support compliance documentation and investigations.

• Drive continuous improvements in processes and methods that reinforce cGMP within the department and/or across the site

• Partner with cross-functional stakeholders to identify, develop, and implement effective Corrective and Preventive Actions (CAPAs) that prevent recurrence of deviations and address underlying issues.

• Analyze and trend deviations, CAPAs, and compliance metrics to identify recurring issues, emerging risks, and opportunities for improvement.

• Develop and implement novel approaches to solving non-routine technical and compliance challenges.

• Communicate information effectively through updates, reports, and summaries.

• Support and participate in internal audits, client audits, and regulatory inspections conducted by global health authorities.

• Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems

• Collaborate with operational teams to implement process improvements while maintaining regulatory compliance.

• Support GMP training or knowledge sharing initiatives to foster a culture of quality, compliance, and continuous improvement.

• Provide routine updates on campaign, project, and investigation status, including risks, challenges, and mitigation plans.

• Provide support and/or direction to junior staff when necessary

• Exercise sound judgment and make data-driven decisions within established quality and compliance frameworks.

• Make critical decisions in collaboration with key stakeholders

• Demonstrate accountability for personal, departmental, and organizational initiatives

Who You Are:

• BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering) with a minimum 4-6 years of experience or an Associate’s degree and a minimum of 10 years of experience in a GMP manufacturing environment 

• Previous hands-on experience in a regulated (eg:GMP/Aerospace) operations environment

• Experience in investigating and helping to resolve production non-conformances, implementing CAPA/Change Controls and leading improvement projects

• Strong proficiency in Microsoft Word, Excel, PowerPoint

• Familiarity with electronic quality management systems (eQMS) such as Veeva, TrackWise, MasterControl, or similar platforms.

• 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

Preferred qualifications

• 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

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.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This role is site based.

• 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 Evotec.

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

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. 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.