MES/Automation Engineer/Sr. Engineer – Technical Operations 

Redmond, WA
Nov 03, 2021
Required Education
Bachelors Degree
Position Type
Full time

Just.Bio is seeking a motivated and creative MES/Automation Engineer/Sr. Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The MES/Automation engineer will be part of the Manufacturing Automation team in the Technical Operations organization to support the design, implementation, and commissioning of MES systems and functionalities to clinical and commercial manufacturing at Just-Evotec Biologics. The engineer may also support manufacturing process automation systems (PAS) using DeltaV. The successful candidate will have demonstrated proficiency in MES deployment and system administration, integration of MES with related business and automation systems, and an understanding of DeltaV automation used for bioprocessing controls systems (SCADA and DCS). Experience working in a GMP environment, change control, and software validation in accordance to GAMP5 guidelines is highly preferred.

Responsibilities (including but are not limited to):
•Collaborate with key stakeholders and provide significant input and guidance in identifying and implementing MES domain and functional domain solutions for clinical and commercial manufacturing
•Apply risk-based approach to develop design requirements and support computer system validation strategy
•Translate process requirements and MES system best practices into practical, usable electronic batch records (MBR design)
•Lead or support integration of MES with external systems such as process control systems (DeltaV), lab equipment and instruments, and other electronic systems (ERP, LIMS, etc.)
•Develop business processes, guidelines, SOPs, and training for the MES system
•Participate in the development of MES system life cycle strategy and business/technical processes for change management
•MES system configuration, programming, troubleshooting, and testing

Position Requirements:
•BS or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
•7+ years of MES experience in Pharmaceutical, Biotech, or Life Sciences industries with 5+ years of experience with current Good Manufacturing Practice (cGMP) Regulations
•Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
•Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards
•Leverage experience of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation
•Knowledge and application of IT infrastructure and applications (server virtualization, security, wireless communication protocols, firewalls, etc.)
•Demonstrated ability to work independently and collaboratively on cross-functional teams.

Additional Preferred Qualifications:
•Previous experience in computer software validation coordinating activities with IT, QA, Warehouse, and Manufacturing
•Leverage expertise using GAMP5 guidelines for risk-based approach to computer system validation
•Applies knowledge and expertise to solve complex technical problems
•Authority inspection or audit support involvement
•Experience with single-use technologies and systems
•DeltaV PAS experience
•Koerber-Werum PAS-X experience

Proficiency developing and executing CSV plans and protocols