Senior Manager, Digital Systems Site MSAT - Redmond, WA

Job Title: Senior Manager, Digital Systems Site MSAT 

Location: Redmond, WA                                                   

Department: Manufacturing

Reports To: Director, Manufacturing Tech Services
 

About Us: this is who we are

At Just Evotec Biologics, 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: Your challenge …in our journey

We’re looking for a passionate and curious Senior Manager, Digital Systems Site MSAT 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 Senior Manager, Digital Systems Site MSAT at Just Evotec Biologics, 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 the Site Automation Team. Responsible for recruitment and employee development in the automation organization.  

• Lead the design and implementation of automation and process control schemes to NPI processes, batch tracking, establishing process control limits, and applying predictive control algorithms. 

• Define site automation support strategy and site roadmap for Delta V, MES, and other process digital systems.  

• Maintain site level validated DeltaV library and lead site level governance and change management system for GMP changes and NPI implementation 

• Participate in engagement with global MSAT Automation teams to support global and site objectives 

• Define strategy for development and optimization of automation engineering documents, specifications, SOP, change controls and training documents.  

• Collaborate with multiple disciplines, including manufacturing, process engineering, process development, data scientists, utility operations, maintenance, quality assurance, and validation to implement operational improvements 

• Provide digital systems project oversight to 3rd party suppliers/contractors.  

• Provide guidance to the team in deviation investigation, technical root cause analysis, and troubleshooting of process control issues.  

• Establish implementation plan and tracking methodology of NCs, CAPAs and change controls to meet site operational needs.  

• Provide leadership to automation representative on the NPI team to ensure all the automation changes/ MES changes are designed/tested as part of NPI readiness.  

• Provide technical support to the manufacturing sites as needed, specific to process control and automation systems 

Who You Are:

• B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering. 

• 10+ years relevant experience in pharmaceutical, biotech, or life sciences 

• Strong control system automation background. Design, installation, programming, and validation of automated processes is essential. 

• Understanding of FDA CFR 21 Part 11 compliance 

• Experienced in deviation investigations, technical root cause analysis, troubleshooting of process control issues and CAPAs/Change controls implementation. 

• Established record of successful project completions employing proven engineering and project management skills 

• Demonstrated skills coding in DeltaV and possess Delta V network knowledge.  

• Demonstrated skills in designed batch records in PASX 

• Authority inspection or audit support involvement 

• Good interpersonal, team, and communication skills are a must,Excellent oral and written. 

 
Additional Preferred Qualifications: 

• Previous experience in computer software validation 

• Participation on global teams, Center of Excellence, etc. 

• Leverage expertise using GAMP5 risk-based appro