Sr Manager, Digital Systems Site MSAT - (Delta-V exp) Redmond, WA
Sr Manager, Digital Systems Site MSAT - (Delta-V exp) Redmond, WA
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Title: Senior Manager Digital Systems Site MSAT
Location: Site based Redmond WA travelling to Seattle 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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits 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: Your challenge in our journey
Were looking for a passionate and curious Senior Manager Digital Systems Site MSAT to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.
As a Senior Manager Digital Systems Site MSATat Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.
What Youll 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 Delta V 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 mustExcellent 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 approach when implementing changes to the validated PAS
Experience with single-use technologies and systems
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. site based roles. 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 mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics
Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Just Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $112560 to $154100;Base salary offered may vary depending on the 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.
Required Experience:
Manager
Employment Type
Full-Time
