Manufacturing Compliance Specialist - Site , Redmond, WA

Location:

Redmond, WA

Department:
Manufacturing Compliance

Reports To:

Director, Manufacturing Compliance

this is who we are At 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?

#BeCurious with us and see where your curiosity can take you!

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.

• 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.

• 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, Track Wise, Master Control, or similar platforms.
• Strong knowledge of cGMP regulations, FDA regulations, ICH guidelines, data…