MES/Automation Engineer/Sr. Engineer - Technical Operations - Washington, Redmond

The announced job offer is made public by the firm: Just - Evotec Biologics and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of Washington at the city Redmond, in the country US - at this current ZipCode: 98052

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Just.Bio is seeking a motivated and creative MES/Automation Engineer/Sr. Engineer that desires a significant opportunity toimprove worldwide access to biotherapeutics. The MES/Automation engineer will be part of the Manufacturing Automation team in the Technical Operations organization to support the management and expansion of the PAS-X Manufacturing Execution System used for clinical and commercial manufacturing at Just-Evotec Biologics. The successful candidate will have demonstrated proficiency in MES deployment and configuration as well as MES integration with related business and automation systems such as Level 4/ERP and Level 2/PCS. Experience with biologics manufacturing processes 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
• Translate process requirements and MES system best practices into practical, usable electronic batch records (MBR recipe design)
• Apply risk-based approach to develop design requirements and support computer system validation strategy
• 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.)
• MES system configuration, programming, testing, and troubleshooting
• Author design documents (configuration, software design specifications) and validation protocols
• Develop business processes, guidelines, SOPs, and training for the MES system
• Support MES system life cycle, expansion strategy, and business/technical process change management
• Participate in internal and external audits/inspections

Position Requirements:

• B.S 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
• 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 a manufacturing process that utilizes single-use technologies and systems
• Experience using DeltaV
• Experience using PAS-X
• Proficiency developing and executing CSV plans and protocols

Worker